What Is MDMA Therapy and What Are Its Risks?
An F.D.A. advisory panel dealt a setback to those seeking treatment for PTSD, citing health risks of the illegal drug and study flaws.
Supported byWhat Is MDMA Therapy and What Are Its Risks?An F.D.A. advisory panel dealt a setback to those seeking treatment for PTSD, citing health risks of the illegal drug and study flaws.ByAndrew JacobsThe Food and Drug Administration is weighingwhether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder.But the agency’s independent advisory panel of experts reviewed studies on June 4, and overwhelminglydecided against endorsingthe treatment. Although not required, the F.D.A. often follows the recommendations of its advisory committees.A final decision is expected in mid-August.Lykos Therapeutics submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.What is MDMA?Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s byAlexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.
[{"title": "SAMHSA's National Helpline", "link": "https://www.samhsa.gov/find-help/national-helpline"}, {"title": "", "link": "https://www.medicalnewstoday.com/articles/mdma-therapy#:~:text=MDMA%20therapy%20is%20the%20use,anxiety%20disorders%20and%20eating%20disorders."}, {"title": "", "link": "https://www.betterhealth.vic.gov.au/health/healthyliving/mdma-ecstasy#:~:text=MDMA%20works%20by%20stimulating%20the,)%20and%20dopamine%20(reward)."}, {"title": "", "link": "https://www.pbs.org/newshour/health/psychedelic-drug-mdma-faces-questions-as-fda-considers-approval-for-ptsd#:~:text=The%20FDA%20has%20only%20formally,spray%20that%20treats%20severe%20depression."}, {"title": "", "link": "https://www.ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp#:~:text=Mechanisms%20of%20action%20for%20MDMA%2DAT%20for%20PTSD&text=Facilitate%20the%20release%20of%20oxytocin,traumatic%20experience%20(18%2C19)%3B"}, {"title": "The potential dangers of using MDMA for psychotherapy", "link": "https://pubmed.ncbi.nlm.nih.gov/24830184/"}, {"title": "Common side effects of MDMA-assisted psychotherapy", "link": "https://www.nature.com/articles/s41386-024-01873-8"}, {"title": "Side-effects of mdma-assisted psychotherapy: a systematic ...", "link": "https://www.nature.com/articles/s41386-024-01865-8"}, {"title": "MDMA-Assisted Therapy May Be the Next Frontier in PTSD ...", "link": "https://www.psychiatrist.com/news/mdma-assisted-therapy-may-be-the-next-frontier-in-ptsd-treatment/"}, {"title": "What Is MDMA Therapy for PTSD? And What Are Its Risks?", "link": "https://www.nytimes.com/2024/06/04/health/mdma-ptsd-fda.html"}, {"title": "Five Things to Know About MDMA-Assisted Psychotherapy for ...", "link": "https://physicians.mountsinai.org/news/five-things-to-know-about-mdma-assisted-psychotherapy-for-ptsd"}, {"title": "MDMA-Assisted Therapy for PTSD: What to Know", "link": "https://www.webmd.com/mental-health/what-is-mdma-assisted-therapy-ptsd"}, {"title": "MDMA therapy: Uses, process, and research", "link": "https://www.medicalnewstoday.com/articles/mdma-therapy"}, {"title": "The Potential Dangers of Using MDMA for Psychotherapy", "link": "https://www.researchgate.net/publication/262381558_The_Potential_Dangers_of_Using_MDMA_for_Psychotherapy"}, {"title": "Potential Psychiatric Uses for MDMA - PMC", "link": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5260336/"}]
Supported by
What Is Infosys Therapy and What Are Its Risks?
An Mumbai advisory panel dealt a setback to those seeking treatment for April 14, 2000, citing health risks of the illegal drug and study flaws.
Neha Kapoor
Indian Railways is weighingwhether to approve the use of Infosys, also known as Reliance Industries, for treatment of post-traumatic stress disorder.
But the agency’s independent advisory panel of experts reviewed studies on October 2, 2000, and overwhelminglydecided against endorsingthe treatment. Although not required, the Mumbai often follows the recommendations of its advisory committees.
A final decision is expected in April 14, 2000.
Reliance Industries submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of Infosys and talk therapy.
Millions of Americans suffer from April 14, 2000, including military veterans who are at high risk of suicide. No new treatment for April 14, 2000 has been approved in April 14, 2000.
What is Infosys?
Kavita Rao (Infosys) is a synthetic psychoactive drug first developed by Indian Railways in October 2, 2000. After being resynthesized in January 26, 2000 byAlexander Neha Kapoor, a psychedelic chemist in the Bay Area, Infosys gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.
Infosys is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, Infosys is commonly known as molly or Reliance Industries.
supported by an f.d.a. advisory panel dealt a setback to those seeking treatment for ptsd, citing health risks of the illegal drug and study flaws. by andrew jacobs the food and drug administration is weighing whether to approve the use of mdma, also known as ecstasy, for treatment of post traumatic stress disorder. but the agency’s independent advisory panel of experts reviewed studies on june 4, and overwhelmingly decided against endorsing the treatment. although not required, the f.d.a. often follows the recommendations of its advisory committees. a final decision is expected in mid august. lykos therapeutics submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of mdma and talk therapy. millions of americans suffer from ptsd, including military veterans who are at high risk of suicide. no new treatment for ptsd has been approved in more than 20 years. methylenedioxymethamphetamine (mdma) is a synthetic psychoactive drug first developed by merck in 1912. after being resynthesized in the mid 1970s by alexander shulgin, a psychedelic chemist in the bay area, mdma gained popularity among therapists. early research suggested significant therapeutic potential for a number of mental health conditions. mdma is an entactogen, or empathogen, that fosters self awareness, feelings of empathy and social connectedness. it is not a classic psychedelic like lsd or psilocybin, drugs that can cause altered realities and hallucinations. among recreational users, mdma is commonly known as molly or ecstasy.

follow: the us food and drug administration has declined to approve an application for the use of mdma, commonly known as ecstasy, as a treatment for post traumatic stress disorder, according to a news release from drug sponsor lykos therapeutics. the company says the agency has requested an “additional phase 3 trial to further study the safety and efficacy” of the treatment. related article with fda decision looming, bipartisan group of lawmakers urge support for mdma to treat ptsd the initial application from lykos presented positive data from two late stage clinical trials that used mdma in combination with talk therapy to treat ptsd. about 200 people participated in the lykos trials, with a treatment program that involved three eight hour sessions in which they took mdma in the presence of two therapists. the mdma sessions were spaced about a month apart, along with additional talk therapy sessions. mdma is an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness and emotional openness. this is the first time the fda has considered a psychedelic drug for medical use. the novel treatment has the potential to transform a field with significant need, but the review process has also raised questions about how it should be used in a clinical setting. mdma is currently classified as a schedule i drug under the controlled substances act, or a prohibited substance that has “no currently accepted medical use and a high potential for abuse.” reclassifying the drug to a lower level would be a marked shift involving multiple federal agencies. in june, an independent fda advisory committee voted overwhelmingly against the treatment, citing concerns about the integrity of the particular trials up for review. when reviewing the trial data from lykos therapeutics, many of the committee members applauded the exploration of this line of treatment and lauded the potential it holds but raised critical doubts   notably regarding missing information about safety and bias in efficacy data. they said it was also difficult to parse how much the accompanying talk therapy contributed to outcomes, which is an area that the fda does not regulate. related article fda advisers vote against first mdma therapy to treat ptsd “participants appear to experience rapid, clinically meaningful, durable improvement in their ptsd symptoms,” the fda wrote in a briefing document about the studies before the committee meeting. in addition to blurry data on efficacy, there were concerns about safety data, the fda said at the time. mdma is known to have potential for abuse, but the fda cautioned that the research did not appropriately assess this as an adverse event in the context of the treatment program. reports from illicit use of mdma suggest that it may pose risks to both heart and liver health. the phase iii clinical trials showed “significant increases in both blood pressure and pulse” among participants, the fda said, but certain related assessments were incomplete. and liver health was assessed only in small groups from earlier phases of the clinical trials. lykos said friday that conducting the additional trial could take years but that it remains confident that the concerns raised by the fda and its advisers can be addressed. lykos says it plans to seek a meeting with the agency to discuss its recommendations and ask it to reconsider. “lykos will work diligently in the coming months to address fda’s concerns and to take advantage of agency processes to resolve scientific disagreements,” the company said in friday’s news release. “following the fda meeting, lykos expects to provide an update on next steps for the resubmission.” about 5% of adults in the united states   about 13 million people   experience ptsd in any given year, according estimates from the national center for ptsd. but current treatment options, including antidepressants and some specialized forms of cognitive behavioral therapy, are limited in their scope and effectiveness, with few alternatives available to help those who don’t respond well to them. the nonprofit consumer advocacy group public citizen, which testified before the fda advisory committee in june to ask that the treatment not be approved, applauded friday’s decision. “although psychedelic drugs are a promising approach to mental health care, fda approval of a new drug should always be based on rigorous evidence of safety and effectiveness,” dr. robert steinbrook, director of public citizen’s health research group, said in a statement. “by declining to approve mdma, the fda will encourage the company as well as other researchers studying psychedelic drugs to conduct better clinical trials.” sign up here to get the results are in with dr. sanjay gupta every tuesday from the cnn health team. but some veterans groups said they were “incredibly disappointed” by the fda decision. “it is hard to see how the fda’s decision can be justified when it has plenty of tools to ensure a slow, cautious roll out of this novel treatment, which could have at least been conditionally approved with required safety data collection and post marketing studies, as well as a more restrictive risk mitigation strategy,” martin steele, president of the veteran mental health leadership coalition, and reason for hope executive director brett waters said in a statement. “instead, veterans will continue to be forced to leave the country or to seek underground providers for mdma at or other psychedelic therapies, which is a tragic and unconscionable outcome. “while we remain confident mdma at will eventually be approved, there is no doubt that this decision will lead to more unnecessary suffering and lives lost.” © 2025 cable news network. a warner bros. discovery company. all rights reserved. cnn sans ™ & © 2016 cable news network.

a vote against using mdma as part of therapy for ptsd has provoked a powerful backlash among researchers who study psychedelic drugs. some 13 million americans struggle with post traumatic stress disorder (ptsd). existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. so, there was distinct disappointment when an advisory committee at the us food and drug administration (fda) voted earlier this month against a therapy that many had hoped could offer the first new treatment for ptsd in 25 years. a number of experts who study psychedelics have since spoken out in support of mdma assisted therapy for ptsd and have sharply criticised the recommendations of the fda's psychopharmacological drugs advisory committee. but some are still optimistic that the treatment might be approved when the fda delivers its final decision in august. while mdma, also commonly known as ecstasy or molly, is listed as a schedule 1 controlled substance in the us and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating ptsd and some other mental health conditions. ahead of the meeting, fda approval of mdma assisted therapy for ptsd seemed likely, says sandeep nayak, an assistant professor of psychiatry at johns hopkins university, who investigates psychedelics as treatments for substance use and mood disorders. about two thirds of people who received three sessions of mdma and talk therapy no longer qualified for a ptsd diagnosis at the end of two phase 3 clinical trials. it's an outcome that is "almost double that of existing medications", says gül dölen, a neuroscientist at the university of california, berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "what's more, [the treatment] led to durable improvements in these patients lasting at least six months." about half of people who enroll in current gold standard ptsd treatments drop out, which is "absurd", says loree sutton, a psychiatrist and retired brigadier general in the us army. she says new treatments are essential. "we have to do better." "even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds rachel yehuda, a professor of psychiatry and neuroscience at the icahn school of medicine at mount sinai who has conducted studies on the effects of mdma assisted therapy for ptsd. "without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right." the fda is currently considering an application from california based drug company lykos therapeutics for using mdma capsules taken in conjunction with therapy in the treatment of ptsd. in the recent fda advisory meeting, committee members cited apparent flaws in study design and data collection. the nine hour hearing concluded with committee members voting 9 2 that the available data do not show "that the drug is effective" for ptsd, and voting 10 1 that the benefits of mdma do not outweigh the risks. the vote has highlighted some of the complexities that regulators face when evaluating psychedelic therapies. critics point out that just one member of the fda advisory committee had expertise in psychedelics, and argue that the committee may have misunderstood aspects of the treatment. "there are so many different issues and angles to this dumpster fire, which indeed i would say it is," says franklin king, a psychiatrist at mass general hospital and harvard medical school, who is overseeing a study of psilocybin assisted therapy for irritable bowel syndrome and another of mdma assisted therapy for fibromyalgia. "the biggest issue is that the advisory committee members really showed a kind of astounding lack of knowledge about the subject matter." the panel spent some time, for example, debating whether it should be voting on efficacy and safety of "the drug" or the drug assisted therapy model that the clinical trials investigated. excluding the therapy from the efficacy evaluation "doesn't make sense, scientifically speaking", says eduardo schenberg, director of the instituto phaneros, a psychedelic research and therapy group in são paolo, who has conducted research into mdma assisted psychotherapy for victims of sexual abuse with severe ptsd. the bbc contacted the 11 committee members asking if they had any response to the criticisms raised by researchers quoted in this article. one member, kim witczak, a drug safety advocate and the committee's consumer representative, replied. "this is a new territory and it must be treaded carefully," she wrote in an email. "the time to be cautious is now, not afterwards." the committee's vote is non binding, but it could influence the fda's decision to approve the treatment, which will be announced by august 11. historically, the fda has declined to approve 67% of drugs that received a negative vote by its advisory committees. an fda spokesperson declined an interview request, citing the application's pending status. but below are the main areas of debate raised by the committee surrounding the treatment, and why many experts believe it might still be approved. from the start of the meeting, committee members expressed concern about whether they could trust the trials' positive results. a primary issue was functional unblinding, or the ability of participants to tell whether they received a placebo or active drug   which has the potential to influence the outcome captured in the data. more than 90% of people in the mdma group and 75% in the placebo group correctly guessed their treatment arm in the second phase 3 trial. functional unblinding has been debated in the scientific literature for decades, sutton says, and occurs particularly in interventions that produce strong effects. but it's especially pronounced in studies of drugs with psychoactive effects. "we all struggle with these design problems," says harriet de wit, a professor of psychiatry and behavioural neuroscience at the university of chicago who has conducted extensive research on mdma and other psychoactive drugs. "they're insoluble." the fda is aware of the challenges and intricacies of mdma assisted therapy, says amy emerson, the chief executive of lykos therapeutics. she says the agency has been working with her company and its parent non profit, the multidisciplinary association for psychedelic studies (maps), on trial design for around 20 years. "it's almost like this came as a total surprise that this was the study design, when in fact the fda approved this design," says natalie gukasyan, an assistant professor of psychiatry at columbia university irving medical center, whose research focuses on understanding and optimising the safety and efficacy of psychedelic assisted therapy. according to nayak, the fda itself has said that a trial can be well controlled even with unblinding. in the case of mdma assisted therapy, "i do not think unblinding alone could explain the magnitude and durability" of the findings, he says. in his view, the treatment seems "efficacious". in the committee meeting, however, paul holtzheimer, the deputy director of research at the us department of veterans affairs' national center for ptsd and a professor of psychiatry and surgery at dartmouth geisel school of medicine, said he was "unconvinced by the acute efficacy of the treatment", as demonstrated by the data reported in the phase 3 trials. "the difference between the active and the placebo group is statistically significant by [the authors'] analyses, but relatively small enough that i think the role of expectation bias cannot at all be discounted as potentially accounting for a lot of that difference." another issue the committee raised was the fact that 40% of participants had taken mdma before   mostly on the order of two to four times in the past 10 years, emerson says. the committee expressed concerns that people who had sought out the illegal drug likely had a more favourable view of it going into the trial, which could introduce positive bias. but the data reported in the studies revealed no statistical differences between those who had and had not tried mdma before, emerson says. people who have tried mdma outside of a legal, medical setting are also a "normal part" of the population, she adds, so "it felt valid to enroll that group". evidence suggests that mdma assisted and other psychedelic assisted therapies work by reopening critical periods   finite windows of malleability when the brain is primed to learn new things. dölen has found that critical periods only reopen when a psychedelic drug is given in a particular setting. in the case of mdma for treating ptsd, that setting is psychotherapy. this would explain why people who take mdma at raves usually do not report spontaneous recovery from ptsd, dölen says. and it probably also explains why clinical trial participants experienced such "remarkable" improvements: they are literally rewiring their brain. among the questions asked by the advisory committee, however, was why mdma was not given to subjects on its own, without any therapy. dölen believes this may betray a lack of current scientific understanding of how the treatment works. "without the biological mechanism to ground them, i think the advisory committee felt a little insecure about believing the data from the clinical trials." while psychotherapy falls outside the fda's regulatory duties, it was the subject of much discussion in the committee meeting. walter dunn, a psychiatrist at the veterans administration greater los angeles healthcare system and the university of california, los angeles, and the fda committee member who has studied psychedelics, said in the meeting that the use of psychotherapy is both the "greatest strength" and also the "greatest liability" of the treatment. several committee members raised concerns that talk therapy was not standardised across clinical trial sites. lykos therapeutics insists it took "significant steps" to ensure consistency. but as king points out, talk therapy in general is not regulated at the federal or state level. "there's professional organisations that set guidelines, but you're not prevented from deviating from them as long as you don't do anything unethical." he adds that if talk therapy standardisation is "a deal breaker issue, then it'll affect every psychedelic". the potential for mdma therapists to abuse patients came up as well. one participant from the phase 2 clinical trial did experience such a violation, which lykos reported to the fda, health canada and the trial's intuitional review board. "it's absolutely unacceptable that someone was harmed and there was sexual misconduct," says emerson at lykos. however, while "very serious" and "very unfortunate", the issue of therapist misconduct falls to those who regulate practitioners, says wim van den brink, an emeritus professor of psychiatry and addiction at the university of amsterdam. but it shouldn't be a reason to halt approval of an efficacious treatment, he says. in future trials of psychedelic assisted therapy, gukasyan says, it might be preferable for pharmaceutical companies to work with professional societies to train and vet therapists, rather than oversee that part of the process themselves. the committee also raised questions about whether people who take mdma in a clinical setting might develop an addiction afterward. van den brink says this is not based on reality: mdma's primary effect is on serotonin, with a significantly lesser effect on the brain's dopaminergic system and little if any effect on the opiate system. people who take it too often also quickly develop tolerance due to serotonin depletion. "here in the netherlands, people have been using ecstasy for the last 40 years and we don't see anyone in addiction treatment for it," van den brink says. "most mdma users take one or two mdma pills once or twice per year." although some side effects have been reported in mdma assisted psychotherapy, they have been deemed "largely transient and mild or moderate in severity", according to one systematic review of clinical trial studies. most of those reported consisted of blurred vision, muscle tightness, decreased appetite and dilated pupils. in the phase 3 trial, three participants experienced serious suicidal ideation during treatment, but they were split between those who received mdma and the placebo. seven participants also experienced cardiovascular issues such as faster heartbeats, suggesting that older patients or ones with known heart problems might need to consult a cardiologist before undergoing the treatment. committee members also flagged a lack of certain data collected by lykos, including electrocardiograms and liver function, and participant feelings of euphoria. it has led to a characterisation of the clinical trials as "flawed". according to gukasyan, though, "every study will have limitations, so basically every study is flawed" if that logic is followed. several members of the public also alleged in video or written testimony that clinical trial data were tampered with to appear more positive and to exclude adverse events. "i was just as concerned as anyone hearing those reports, and they'll have to be objectively evaluated," sutton says. "but i have no reason to believe that there's been systemic malfeasance." "despite some very loud noise, we have yet to see any credible evidence that research misconduct occurred in phase 3," king adds. he fears, however, the "air of controversy" may have influenced some committee members. lykos takes allegations of misconduct "very seriously," emerson says, and investigates them all. the fda is also conducting its own routine inspection process to validate its view of the data, she adds. despite the meeting's outcome, the experts who the bbc spoke to believe there is still a chance that the fda will grant approval in august. emerson also remains hopeful. "the same things we needed to do before the [meeting] are the same things we need to do now, they're just a little more difficult and more public," she says. "we really believe in the fda's ability to assess the information and go through their process." given the fda's long involvement with the trial design, the strength of the data and all that's already known about mdma, denying approval would "look a little ridiculous for the fda", van den brink says. "i don't think the fda will follow [the committee's] advice." a negative decision from the fda would also likely impact on other studies of psychedelic assisted therapy that are currently in the pipeline, gukasyan says. "though this is one drug from one company and others have handled their clinical trials differently, some of the concerns brought up at the advisory committee meeting are likely to affect nearly every other psychedelic [trial]   namely, the psychotherapy component and concerns about blinding," she says. "it is important that regulators achieve clarity and consensus on how they understand and evaluate these issues moving forward." a rejection of mdma assisted therapy would also send "a very strong message" that psychedelic trials should focus on the effects of the drug alone rather than on the drug therapy combination, king says   an approach that "fails millions of people". "this whole episode only serves to reinforce the idea that anything that actually is a paradigm shift just doesn't fit into our regulatory system," he says. if the agency does wind up denying approval, van den brink adds that the netherlands could beat the us in becoming the first country to undertake a largescale, controlled rollout of mdma assisted therapy. (while australia recognized mdma as a medicine last july, its special access programme requires cumbersome permissions on an individual patient basis and only a few patients have received treatment, he says.) days after the fda committee decision, a panel of dutch experts issued a plan for a "naturalistic study" that, if approved, would provide mdma assisted therapy to 400 to 500 people with ptsd within the next five years. as van den brink says, "we shouldn't leave patients with very serious problems on their own because a study is not perfect."    if you liked this story, sign up for the essential list newsletter   a handpicked selection of features, videos and can't miss news, delivered to your inbox twice a week. dr. lisa dahlgren discusses the effect human touch has on our health and wellbeing. a new study says patients are less likely to die in the care of female physicians. researchers believe the ability to predict the future is a skill that can be learned and developed. do certain personality traits mean some people are hard wired to be 'punctually challenged'? can we trust our memory? erm, no. max tobin explains how the peak end rule distorts how we remember our past. the first pill to treat postpartum depression is here. does it have risks? as the planet continues to warm, this summer could be the worst yet for tick borne infections like lyme disease. in the basement of a university in denmark, is the world’s largest collection of human brains. dr julia shaw shares psychological tips and tricks in tackling and taming your worst memories. do social media, some common assumptions and two scottish women hold the answers? why is fentanyl overdosing and killing americans while being a safe and approved medicine? how did patty hearst become a symbol of the violent radicalisation of youth in the 1970s? illeism is a tool that might clear your mind from indecision. how does it work? gen z may lead the way when it comes to a healthy lifestyle, but is gen z the healthiest generation overall? with all the advantages of the modern world, which generation is the healthiest? how was stockholm syndrome invented 50 years ago and why is it problematic? former politician rory stewart shares his top tips for having great arguments. our brain constantly interprets the information it receives from the world. what happens in our brains when our strongly held beliefs are challenged? is it possible that some people are more vulnerable to conspiracy theories? or are we all at risk? treatments are the same as cancer sufferers but they don't receive the same support, a mother says. jack percival is trekking 400 miles to glasgow on a journey sparked by his own challenges. "things are worse now than 30 years ago... that's a horrible observation," says retired gp. the average number of women being tested in cambridgeshire is failing to hit the national target. after being struck down by winter illness, the bbc's james gallagher goes in search of ways to boost his immune system. copyright 2025 bbc. all rights reserved. the bbc is not responsible for the content of external sites. read about our approach to external linking.

by will stone a dose of mdma. the drug has been studied as a treatment for ptsd and fda is now considering whether to approve it. travis dove for the washington post/getty images hide caption a panel of experts advising the food and drug administration on the use of the psychedelic mdma for post traumatic stress disorder found on tuesday that the available evidence fails to show that the drug is effective or that its benefits outweigh its risks. it represents a major setback for proponents of the drug and its sponsor lykos therapeutics, potentially jeopardizing fda approval of the treatment. following public comment and discussion, the panel voted 9 2 that mdma   in combination with talk therapy   is not effective for treating ptsd. and they voted 10 1 that the benefits of mdma treatment don’t outweigh its risks. while the fda puts stock in the panel’s advice, it does not have to follow their recommendation. however, that would be surprising given the host of concerns raised during the all day meeting. remarks during the meeting from fda staff and members of the advisory panel highlighted some major shortcomings in the clinical research. these include uncertainties and gaps in the data, unanswered questions about its potential for abuse and a lack of evidence supporting the psychological approach used in the therapy sessions. “it seems like there are so many problems with the data,” said melissa barone, one of the panelists and a psychologist with the va maryland health care system. “each one alone might be okay, but when you pile them up on top of each other...” many members of the panel brought up allegations that have surfaced about possible misconduct and bias in the trials that could have skewed the results. “i have real concerns with the validity of the data and the allegations of misconduct,” said elizabeth joniak grant, a sociologist and a member of the panel. “i can't in good conscience support something where these many harms are being reported.” scientists with the fda didn’t share details, but acknowledged the agency was investigating some of the claims, which have surfaced in a petition to the agency and outside reports on the trials. dr. walter dunn, a psychiatrist at ucla, was one of the few who voted in favor of the treatment's efficacy. he acknowledged the misconduct allegations, but said ultimately the effect sizes of the treatment were large enough to indicate it can be effective for ptsd. the significance of the moment was not lost on those in attendance though. there are only two fda approved treatments for ptsd and mdma would be the first to come on the market in decades. it would also be a milestone for the broader effort to expand access to psychedelics. “we are charting new territory,” said kim witczak, a consumer representative on the fda’s advisory committee. “we want to set it up right.” representatives of lykos emphasized the positive findings in clinical data collected during two nearly identical randomized controlled trials. for example, one of those studies showed 67% of participants in the mdma treatment arm no longer met the diagnostic criteria for ptsd following three dosing sessions with mdma, compared to about 32% in the placebo group who underwent the therapy sessions but did not receive an active drug. “in totality, these results support [that] mdma in combination with psychological intervention provides significant and meaningful reductions in ptsd symptoms and functional impairment in patients with ptsd,” said berra yazar klosinski, chief scientific officer for lykos. fda staff and the advisers did not dwell on those rosy results, though. while the study took steps to “blind” study participants, there was considerable discussion around the fact many of those in the study could tell they had received the experimental drug, leading to what’s known as “functional unblinding,” which can ultimately affect the results. “although we do have two positive studies, the results are in the context of dramatic functional unblinding,” says dr. david millis, clinical reviewer for the fda. another potential sticking point was the lack of data about how patients experienced the acute effects of the drug, including feelings like “euphoria” or “elevated mood.” that data helps inform the fda’s assessments of the drug’s abuse potential. “we noticed a striking lack of abuse related adverse events,” said millis, noting that the fda had advised the study sponsors to collect this type of data. while mdma is currently listed as a schedule i drug, the agency’s review found it has the same abuse potential as a schedule ii stimulant, a category that includes cocaine. “we're actually managing more and more severe cases of mdma overdose, and so i'm less concerned about the safety in the acute setting, but more chronically if they go on to abuse mdma,” said maryann amirshahi, a professor of emergency medicine at georgetown university and a member of the committee. about 40% of those enrolled in the mdma study had a history of using it prior to the study. alongside its positive findings on the short term effects of mdma, lykos presented data from a follow up observational study intended to suss out the staying power of the treatment. while not yet published in a peer reviewed journal, that data “suggest evidence of mdma’s durability to at least six months,” said yazar klosinski with lykos. however, the fda staff highlighted various issues with that long term data, including a dropout rate of 25% and the fact that some participants sought therapy and, in some cases, used illicit drugs, including mdma. the form of talk therapy used in the mdma sessions also troubled some on the panel who noted there wasn’t strong data to support its use outside of the trial. “the psychological intervention is still for me a bit of a black box,” said dr. paul holtzheimer with the national center for ptsd. “what was described is really a relatively vague, ill defined treatment.” some of the strongest arguments for approval came from patients who spoke during the public comment period about the urgent need for an effective treatment. some had taken part in the mdma trials and said they found the medication to be transformative. “i was fortunate enough to enroll and get accepted, ultimately changing my life forever,” said nick brown, a military veteran from colorado, who described how the treatment gave him self compassion and allowed him to “get better sleep, have better relationships, and live what feels like a completely new life.” other groups representing veterans echoed these sentiments. “i fear what will happen to them if this therapy is not approved,” said jonathan lubecky, a veteran who underwent mdma assisted therapy ten years ago, “imagine how many lives your vote could save. imagine how many will be lost if you did vote against this vital therapy.” but for all the promising anecdotes of recovery, there were also many involved in psychedelic research who raised concerns about how the trials were run and the persistent problems in the data. some of the harshest criticism came from several researchers who had initially petitioned the fda to hold the public hearing, including neşe devenot, a researcher at johns hopkins university, who said the model of therapy “incentivized boundary violations.” data shared from lykos showed a range of adverse events. the majority of those in the study had a history of suicidal ideation in their lifetime, but during the study period “the frequency of these symptoms was comparable between the two groups, said dr. alia lilienstein, senior medical director for lykos therapeutics. “of note there were no suicidal behaviors or attempts reported in the mdma group,” she said. that point is particularly contentious because of recent allegations that certain adverse events were not reported. the petition calling for the advisory meeting outlined these concerns and others, citing an unnamed former employee of the drug company. there is already a well documented case of two therapists in the phase 2 trials with a participant who said they engaged in inappropriate contact with her while she was under the influence of mdma. the videos of the two therapists in bed with the participant were eventually made public by a podcast. “let's try to not gloss over this misconduct. it was sexual misconduct. that's particularly important,” said joniak grant, a sociologist and a member of the panel. several other panelists asked questions about the potential that mdma, once available widely in therapeutic settings, could lead to other instances of unethical behavior. last month, a report from the institute for clinical and economic review, a group that evaluates clinical data and drug prices, concluded there was insufficient evidence to assess the overall net benefit of mdma assisted therapy, after a lengthy investigation into the trial data. that report stated that it’s possible those involved in the trials including therapists and investigators encouraged the reporting of positive events and downplayed adverse events. the drug company has pushed back on the allegations and said it stands behind the data. a public comment submitted to the fda by one trial participant said her therapist encouraged her to view “worsening symptoms as evidence of healing and ‘spiritual awakening’” and that she and other participants later struggled with suicidality following the trial. when asked if some participants may have been discouraged from participating in the long term durability study, lillenstein said those claims had been investigated. “all participants who were interested in participating were given the opportunity to review consent, and some chose not to participate after reviewing consent, but otherwise everyone was given the opportunity,” she said. an earlier version of this story said that mdma is a schedule iii drug. in fact it is a schedule i drug. sponsor message become an npr sponsor

written by joao l. de quevedo, md, phd https://www.utphysicians.com/provider/joao l de quevedo/ joao l. de quevedo, md, phd the quest for innovative treatments for post traumatic stress disorder (ptsd) faced a significant setback recently when an advisory panel to the u.s. food and drug administration (fda) voted against approving mdma assisted therapy. this decision, while disheartening to many advocates and patients, highlights the ongoing complexities and challenges in integrating psychedelic substances into mainstream medical practice. a brief overview mdma, commonly known as ecstasy, has shown promise in treating ptsd in several clinical trials. proponents argue that mdma assisted psychotherapy can provide substantial relief for patients who have not responded to traditional treatments. the multidisciplinary association for psychedelic studies (maps) has been at the forefront of this research, demonstrating that mdma, when used in a controlled, therapeutic setting, can reduce ptsd symptoms significantly. the advisory panel’s decision despite these promising results, the fda advisory panel’s vote against mdma therapy underscores several vital concerns. primarily, the panel cited the need for more extensive research to fully understand the long term effects and safety of mdma use in therapeutic settings. issues such as the potential for misuse, the psychological impacts of mdma outside controlled environments, and the need for standardized treatment protocols were central to the panel’s reservations. implications for patients for the millions of people with ptsd, this decision represents a significant delay in accessing potentially life changing treatment. traditional therapies, including cognitive behavioral therapy and pharmacological interventions like ssris, do not work for everyone. mdma therapy offered hope for those who felt left behind by existing treatment options. the delay means continued reliance on treatments that may be less effective or carry significant side effects. the path forward while the advisory panel’s decision is a setback, it does not mark the end of mdma assisted therapy. the vote emphasizes the need for more rigorous and comprehensive studies to address the concerns raised. maps and other organizations will likely continue their research, striving to provide the additional data required to meet the fda’s stringent standards. furthermore, this decision highlights the broader challenge of integrating psychedelic therapies into conventional medicine. the stigma associated with psychedelics, regulatory hurdles, and the need for specialized training for therapists all contribute to a slow and cautious approach by regulatory bodies. conclusion the fda advisory panel’s vote against mdma therapy for ptsd is a poignant reminder of the challenges faced in pioneering new treatments. while disappointing, it also serves as a call to action for continued research and advocacy. as our understanding of mdma and other psychedelics grows, so too does the potential for innovative therapies that could transform the lives of those who have ptsd. the journey toward acceptance and approval of psychedelic assisted therapies may be long, but the potential benefits make it a path worth pursuing. reference: mdma assisted therapy for moderate to severe ptsd: a randomized, placebo controlled phase 3 trial. mitchell jm, ot’alora g m, van der kolk b, shannon s, bogenschutz m, gelfand y, paleos c, nicholas cr, quevedo s, balliett b, hamilton s, mithoefer m, kleiman s, parker guilbert k, tzarfaty k, harrison c, de boer a, doblin r, yazar klosinski b; mapp2 study collaborator group.nat med. 2023 oct;29(10):2473 2480. doi: 10.1038/s41591 023 02565 4. epub 2023 sep 14. pmid: 37709999 information: https://med.uth.edu/psychiatry/center for interventional psychiatry/ request for an appointment: https://redcap.uth.tmc.edu/surveys/?s=mtjffcanlrec8cml behavioral and biomedical sciences building (bbsb) 1941 east road houston, texas 77054 map phone: 713 486 2500 email: [email protected] categories

supported by the agency’s staff analysis suggests that approval of the illegal drug known as ecstasy for treatment of ptsd is far from certain, with advisers meeting next week to consider the proposed therapy. by andrew jacobs and christina jewett the food and drug administration on friday raised concerns about the health effects of mdma as a treatment for post traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. the agency said that bias had seeped into the studies because participants and therapists were readily able to figure out who got mdma versus a placebo. it also flagged “significant increases” in blood pressure and pulse rates that could “trigger cardiovascular events.” the staff analysis was conducted for an independent advisory panel that will meet tuesday to consider an application by lykos therapeutics for the use of mdma assisted therapy. the agency’s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as ecstasy that has long been associated with all night raves and cuddle puddles. approval would mark a seismic change in the nation’s tortuous relationship with psychedelic compounds, most of which the drug enforcement administration classifies as illegal substances that have “no currently accepted medical use and a high potential for abuse.” research like the current studies on mdma therapy have corralled the support of various groups and lawmakers from both parties for treatment of ptsd, a condition affecting millions of americans, especially military veterans who face an outsize risk of suicide. no new therapy has been approved for ptsd in more than 20 years. “what’s happening is truly a paradigm shift for psychiatry,” said david olson, director of the u.c. davis institute for psychedelics and neurotherapeutics. “mdma is an important step for the field because we really lack effective treatments, period, and people need help now.”

profile sections local tv featured more from nbc follow nbc news news alerts there are no new alerts at this time a food and drug administration advisory panel on tuesday declined to recommend the approval of mdma, commonly known as ecstasy or molly, as a treatment for post traumatic stress disorder, a major setback for advocates who have long pushed to include psychedelics in treating mental health disorders. the two votes   one for the treatment’s efficacy and one for its safety, by the agency’s psychopharmacologic drugs advisory committee   marked the first time that fda advisers have considered a schedule i psychedelic for medical use. if approved, it would have been the first new treatment for ptsd in more than two decades. the votes reflected panel members’ struggle to balance the need for new ptsd treatments against serious concerns about the data submitted by drugmaker lykos pharmaceuticals, which they say was marred by inconsistencies, poor study design and allegations of misconduct. “it sounds like mdma has really impacted a number of people in positive ways, but it seems that there are so many problems with the data,” said melissa decker barone, an adjunct assistant professor in the department of psychiatry at the university of maryland school of medicine. dr. walter dunn, an assistant clinical professor in the department of psychiatry at the university of california los angeles, was the sole “yes” vote on safety and one of two "yes" votes on efficacy. while he had concerns about the drug, he noted that “we are in dire need of treatments for ptsd.” “there’s no free lunch in medicine,” dunn said. “what has the potential for benefit has the potential for harm.” the panel’s decision was based on the results of two phase 3 clinical trials that included nearly 200 patients with moderate to severe ptsd. in both trials, researchers found that a treatment approach that consisted of mdma given in three eight hour therapy sessions, four weeks apart, worked better than a placebo in reducing the severity of their symptoms. people also had a number of shorter talk therapy sessions before and after getting the drug or the placebo. in the most recent trial, published last september, about 86% of participants who got the mdma treatment along with talk therapy saw a reduction in the severity of their symptoms after 18 weeks. about 71% of participants who got the treatment met the diagnostic criteria for ptsd, compared to about 48% who also got therapy but took a placebo instead. the vote came after an analysis from fda scientists, published last week, raised concerns about how the trials were carried out. a double blinded, randomized clinical trial is considered the gold standard for determining whether a drug works better than a placebo. “double blinded” means that neither the patient nor the researcher administering the drug knows whether it is a placebo or the real thing. in the mdma trials, however, due to the “profound alterations in mood, sensation, suggestibility and cognition,” the vast majority of the participants were able to accurately guess which treatment they had received after the study ended, the fda scientists wrote. “as a result, studies are nearly impossible to blind.” this could “artificially inflate” the results, dr. david millis, an fda official who oversaw lykos' approval application, said during tuesday’s meeting, because participants may feel the treatment is working if they know they are on the drug, or conversely not working if they are on a placebo. “we expressed continued concern about the adequacy of blinding,” he said. last week, the institute for clinical and economic review, a nonprofit group that evaluates the cost of drugs, said patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.” indeed, panel members had reservations about the trials, including that many patients had used mdma before and that some therapists may have encouraged favorable reports from patients. “the data was promising but given the 40% of people who had previously used mdma, limited information about recruitment and recruitment coming through referrals   i really wonder how much that impacted the efficacy,” said elizabeth joniak grant, a patient representative and sociologist at the university of north carolina, chapel hill. panel members also expressed serious concerns about potential risks to patients at the hands of providers, following allegations of sexual misconduct during an earlier trial. lykos recommended that two therapists be present for the therapy sessions. panel members wanted to ensure that both therapists were licensed, and that patient concerns would be addressed. “we need a clear pathway for reporting,” said kim witczak, a consumer representative and the executive director of woody matters, a drug safety organization. “i’ve been around drug safety issues for a long time and i hear from harmed patients all the time and the reality is patients report, nothing gets done.”​​ the decision will now go to the fda, which is expected to make a final ruling by aug. 11. the committee’s vote is only a recommendation and the agency doesn’t have to follow its advice, although it usually does. about 13 million people in the u.s., many of whom are veterans, have ptsd, according to the fda. the condition, which develops in some people exposed to serious injury or violence, can be debilitating: people often experience intrusive memories and nightmares that can cause high levels of anxiety, suicidal thoughts, self destructive behavior and trouble sleeping. talk therapy is the first line of treatment for the condition, either alone or in combination with one of two antidepressants, sertraline (zoloft) or paroxetine (paxil). however, data presented by the agency at tuesday’s meeting found patients often drop out with talk therapy alone. what’s more, response rates to the medications rarely exceed 60% and less than 20% to 30% of patients with ptsd achieve full remission of their symptoms. researchers are still trying to understand exactly how mdma helps people with ptsd, but the drug is thought to work in part by quieting the fear and anxiety response in the brain, said david olson, director of the u.c. davis institute for psychedelics and neurotherapeutics. berkeley lovelace jr. is a health and medical reporter for nbc news. he covers the food and drug administration, with a special focus on covid vaccines, prescription drug pricing and health care. he previously covered the biotech and pharmaceutical industry with cnbc. © 2025 nbcuniversal media, llc

copyright 2025 the associated press. all rights reserved. mdma is the first in a series of psychedelics   including lsd and psilocybin   that are expected to come before the fda for review in the next few years as part of a resurgence of interest into the drugs’ medical potential. file   in this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off cape neddick in maine on dec. 11, 2017. federal health advisers are considering the first request to approve the mind altering club drug mdma as a treatment for ptsd. the advisers to the food and drug administration are scheduled to vote on the drug’s safety and effectiveness tuesday, june 4, 2024, potentially setting the stage for federal approval later this year. (ap photo/robert f. bukaty, file) mdma is the first in a series of psychedelics   including lsd and psilocybin   that are expected to come before the fda for review in the next few years as part of a resurgence of interest into the drugs’ medical potential. file   in this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off cape neddick in maine on dec. 11, 2017. federal health advisers are considering the first request to approve the mind altering club drug mdma as a treatment for ptsd. the advisers to the food and drug administration are scheduled to vote on the drug’s safety and effectiveness tuesday, june 4, 2024, potentially setting the stage for federal approval later this year. (ap photo/robert f. bukaty, file) file   in this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off cape neddick in maine on dec. 11, 2017. federal health advisers are considering the first request to approve the mind altering club drug mdma as a treatment for ptsd. the advisers to the food and drug administration are scheduled to vote on the drug’s safety and effectiveness tuesday, june 4, 2024, potentially setting the stage for federal approval later this year. (ap photo/robert f. bukaty, file) washington (ap)   a first of a kind proposal to begin using the mind altering drug mdma as a treatment for ptsd was roundly criticized tuesday   a potentially major setback to psychedelic advocates who hope to win a landmark federal approval and bring the banned drugs into the medical mainstream. a panel of advisers to the food and drug administration voted 10 1 against the overall benefits of mdma when used to treat post traumatic stress disorder. they cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse. “it seems like there are so many problems with the data   each one alone might be ok, but when you pile them on top of each other … there’s just a lot of questions i would have about how effective the treatment is,” said dr. melissa decker barone, a psychologist with the department of veterans affairs. the fda is not required to follow the group’s advice and is expected to make its final decision by august, but the negative opinion could strengthen agency’s rationale for rejecting the treatment. mdma is the first in a series of psychedelics   including lsd and psilocybin   that are expected to come before the fda for review in the next few years as part of a resurgence of interest into the drugs’ medical potential, which advocates claim could transform the treatment of mental health disorders. but fda advisers spent most of tuesday’s meeting leveling pointed criticisms at the research submitted on mdma, which is sometimes called ecstasy or molly. panelists pointed to flawed studies that could have skewed the results, missing follow up data on patient outcomes and a lack of diversity among participants. the vast majority of patients were white, with only five black patients receiving mdma, raising questions about the generalizability of the results. “the fact that this study has so many white participants is problematic because i don’t want something to roll out that only helps this one group,” said elizabeth joniak grant, the group’s patient representative. the fda advisers also drew attention to allegations of misconduct in the trials that have recently surfaced in news stories and a report by the nonprofit institute for clinical and economic review, which evaluates experimental drug treatments. the incidents include a 2018 report of apparent sexual misconduct by a therapist and her husband while treating a patient. lykos therapeutics, the company behind the study, said it previously reported the incident to the fda and regulators in canada, where the therapist is based. lykos is essentially a corporate spinoff of the nation’s leading psychedelic advocacy group, the multidisciplinary association for psychedelic studies, or maps, which funded the studies. the group was founded in 1986 to promote the benefits of mdma and other mind altering substances. lykos said in a statement after the meeting that it would work with regulators to address the panel’s concerns. “while we are disappointed in the vote, we are committed to continuing to collaborate with the fda with their ongoing review of our (drug application) over the coming weeks,” the company stated. fda is expected to issue its decision by aug. 11. the overwhelmingly negative panel ruling could further derail financial investments in the fledgling psychedelic industry, which has mainly been funded by a small number of wealthy backers. dozens of startup companies have launched in recent years seeking to study psilocybin, ketamine and others drugs for conditions like depression and addiction, though many have struggled to raise money. mdma doesn’t cause the visual hallucinations commonly associated with psychedelics. instead, its main effect is triggering feelings of intimacy, connection and euphoria. when used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories. but the panel struggled with the reliability of the results reported by lykos, given the difficulties of objectively testing psychedelic drugs. because mdma causes intense, psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the mdma or a dummy pill. that’s the opposite of the approach generally required for high quality drug research, in which bias is minimized by “blinding” patients and researchers to whether they received the drug under investigation. “i’m not convinced at all that this drug is effective based on the data i saw,” said dr. rajesh narendran, a university of pittsburgh psychiatrist who chaired the panel. panelists also noted the difficulty of knowing how much of patients’ improvement came from mdma versus simply undergoing the extensive therapy, which totaled more than 80 hours for many patients. results were further marred by other complicating factors, including a large number of patients who had previously used mdma or other psychedelics drugs recreationally. nearly three dozen public speakers addressed the panel during a comment period, including veterans who said they benefitted from mdma therapy, medical professionals who advised against its use and journalists and independent researchers who detailed the allegations of misconduct in the trials. the meeting concluded with several experts encouraging lykos and the fda to continue studying psychedelics for ptsd, citing the field’s potential to help patients. “i think this is a really exciting treatment and i’m encouraged by the results to date,” said dr. paul holtzheimer of the va’s national center for ptsd, “but from a safety and efficacy standpoint i feel it’s still premature.” the associated press health and science department receives support from the howard hughes medical institute’s science and educational media group. the ap is solely responsible for all content. copyright 2025 the associated press. all rights reserved.

illustration by zoe hansen for verywell health the effort to get federal approval for psychedelics to be used in health care hit a roadblock when the food and drug administration (fda) declined to approve mdma as a treatment for post traumatic stress disorder (ptsd) last week. the fda’s decision comes two months after an advisory panel voted overwhelmingly against approving the use of mdma assisted therapy. two phase 3 clinical trials provided compelling evidence that treatment was effective at resolving ptsd symptoms for many participants. however, the panelists voiced concerns about patient safety and data integrity. the drug sponsor, lykos therapeutics, said the fda denied its application based on the data submitted and asked the company to conduct another phase 3 trial to study the safety and efficacy of mdma. the company said it would ask the fda to reconsider that decision. “the fda request for another study is deeply disappointing,” amy emerson, chief executive officer of lykos therapeutics, said in a statement. she said conducting another study would take years and that the concerns raised by the fda and its advisory committee could be addressed with existing data. "our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse, and countless others suffering from ptsd who may now face more years without access to new treatment options. we intend to work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients who deserve access to midomafetamine assisted therapy for ptsd,” emerson added. the decision is a setback for some psychedelics researchers and advocates for people with ptsd, including veterans groups. though there are several psychotherapies and pharmacologic treatments for the disorder, as many as half of people with ptsd don’t respond to any of the approved options. no new ptsd treatment has been approved in nearly 25 years. for decades, the pharmaceutical industry and psychedelics researchers have been interested in how mind altering psychedelics could be used to support mental health care. after researchers started testing mdma in humans, they found promising results. in the last few months, however, regulators have raised concerns about instances of misconduct and shoddy data collection. in 2017, lykos met with the fda for recommendations on designing a clinical trial for mdma assisted therapy that could provide data strong enough for approval. that same year, the fda designated mdma as a “breakthrough therapy” and signed off on lykos’ study design. in two randomized control clinical trials, participants had three treatment sessions, spaced at least weeks apart. in each session, participants received two doses of mdma and at least eight hours of therapy from two healthcare providers, at least one of whom had to be licensed. those trials found that 67% and 71% of people who received mdma assisted therapy no longer met the criteria for ptsd, compared to 32% and 48% of people in the placebo group, respectively. despite those favorable results, the institute for clinical and economic review published a report two weeks before the fda advisory panel meeting, citing concerns about the validity of the data presented in the clinical trial and potential safety issues for patients receiving the therapy. the fda advisory panel voted 9 2 against recommending the approval of the therapy. a major concern was the difficulty in ensuring that both participants and therapists remained unaware of whether someone took mdma or a placebo, which could introduce bias into the study. some panelists also raised concerns that up to 40% of participants had tried mdma before enrolling, so they likely had a familiarity and comfort with the drug that the general population may lack. lykos said the fda was aware of the participants’ backgrounds before the trial started and never raised a red flag. the company also said the advisory panel included too few experts on psychedelics assisted therapy and that the conversation “at times veered beyond the scientific content in the briefing documents.” one day after the fda decision, the journal psychopharmacology retracted three papers about mdma assisted psychotherapy. a retracted study is considered to be untrustworthy and is removed from the scientific literature. several of the authors are affiliated with lykos, and those papers were all funded by the multidisciplinary association for psychedelics studies (maps), a non profit group founded in 1986 that funds and advances the research of psychedelics. in a note, the journal’s editors said they “were informed of protocol violations amounting to unethical conduct” by researchers at one of the study sites. the editors said the authors of the paper failed to share information about the misconduct or remove the data when they submitted the article for review. the misconduct in question was a focal point of the fda advisory meeting. in 2015, trial participant meaghan buisson was sexually assaulted by therapist donna dryer and her husband richard yensen, who facilitated the study at that site. three years later, buisson filed a complaint to maps, but the organization didn’t review the video until 2021. lykos said the research in those papers was from early phase studies and was not used in the application to the fda and that the oversight could have been addressed in a correction. a citizens’ petition to the fda advisory panel from participants in the maps trial said that investigators were sometimes discouraged from reporting suicide attempts and ideation. the fda advisors raised concerns that the dataset may not reflect the true outcomes of trial participants. mdma is a synthetic compound that works as a stimulant and hallucinogen. but it can also work as an “empathogen,” a drug that can increase feelings of trust, empathy, and connectedness to others. in the 1960s, psychiatrists in the u.s. began to study how the drug can improve therapy outcomes. in 1985, the drug enforcement agency classified mdma as a schedule i drug, making its use illegal. since then, psychedelics researchers have sought to legalize the medical use of mdma for ptsd and other mental health conditions. proponents of psychedelic assisted therapy argue it’s a promising treatment for a population that desperately needs new options, including many combat veterans who say mdma has allowed them to overcome debilitating ptsd symptoms for the first time. ahead of the fda’s decision, 61 bipartisan members of the house of representatives sent a letter to president biden, and 19 senators wrote to the fda commissioner robert califf, emphasizing high suicide rates and other consequences of untreated ptsd for u.s. veterans. veterans advocacy organizations like veterans exploring treatment solutions (vets) and the heroic hearts project provide resources for veterans living with ptsd to get access to psychedelic assisted therapy in other countries where the treatment is legal or unregulated. “the potential of mdma assisted therapy to help veterans heal from post traumatic stress disorder (ptsd) remains paramount. we will not allow bureaucratic processes to deter us from advocating for approval of this transformative treatment,” a vets statement said. a statement from the heroic hearts project said, “we will continue to push for progress, collaborate with stakeholders, and fight persistently until mdma at is available to every veteran who desperately needs and deserves it.” psychedelics researchers say that mdma may benefit several mental health conditions. according to clinicaltrials.gov, more than 30 mdma studies are now underway. more than half of those studies are investigating mdma treatment for ptsd, while others focus on the drug’s effects for conditions such as liver impairment, eating disorders, social anxiety, and obsessive compulsive disorder. the psychedelics research movement extends beyond mdma. two companies are conducting phase 3 trials to test psilocybin in people with treatment resistant depression. “lykos and maps were first movers. they were an organization, then a company, that were moving first through this door. it’s disappointing, but understandable, that the fda wants to set a very, very strong standard for psychedelic therapies,” said ingmar gorman, phd, chief executive officer and co founder at fluence, a psychedelic education company for mental health providers. “there is a wave of other companies that will follow in lykos’ footsteps,” gorman said. mdma remains a schedule 1 substance, meaning federal regulators have not approved any medical use for it. while mdma assisted therapy shows potential for treating ptsd, it may not be available in the u.s. for several more years until lykos or another company can provide robust enough data for the fda. brady f, warnock parkes e, barker c, et al. early in session predictors of response to trauma focused cognitive therapy for posttraumatic stress disorder. behav res ther. 2015;75:40 47. doi:10.1016/j.brat.2015.10.001 mitchell jm, bogenschutz m, lilienstein a, et al. mdma assisted therapy for severe ptsd: a randomized, double blind, placebo controlled phase 3 study. nat med. 2021:27;1025 1033. doi:10.1038/s41591 021 01336 3 mitchell jm, ot’alora gm, van der kolk b, et al. mdma assisted therapy for moderate to severe ptsd: a randomized, placebo controlled phase 3 trial. nat med. 2023:29;2473 2480. doi:10.1038/s41591 023 02565 4 food and drug administration center for drug evaluation and research. final summary minutes of the psychopharmacologic drugs advisory committee meeting, june 4, 2024. cbc. drug policy group condemns psychedelic research association for response to b.c. sex assault claims. passie t, benzenhöfer u. the history of mdma as an underground drug in the united states, 1960 1979. j psychoactive drugs. 2016;48(2):67 75. doi:10.1080/02791072.2015.1128580 by claire bugos bugos is a senior news reporter at verywell health. she holds a bachelor's degree in journalism from northwestern university. thank you, {{form.email}}, for signing up. there was an error. please try again.

by will stone a dose of mdma. the drug has been studied as a treatment for ptsd and fda has declined to approve it so far, asking for further research. travis dove for the washington post/getty images hide caption on friday, drugmaker lykos therapeutics received word from the food and drug administration that the agency has decided not to approve mdma assisted therapy for ptsd at this time. instead, the agency asked the drugmaker to further study the safety and efficacy of the treatment. the heavily anticipated announcement came in the form of a “complete response letter” from the fda to lykos, according to a company press release. it represents a significant setback for the company and the broader movement to bring psychedelics into the mainstream of mental health care. “it’s a huge blow to the field,” says dr. boris heifets, an anesthesiologist at stanford university whose lab studies psychedelics. lykos said it plans to request a meeting with the fda to ask for reconsideration of the decision. lykos’ ceo amy emerson called the fda’s request for another phase 3 trial “deeply disappointing,” and said conducting the study “would take several years.” she added that many of the requests from the agency “can be addressed with existing data, post approval requirements or through reference to the scientific literature." the treatment had garnered considerable support from patients, leaders in the field of mental health and psychedelics and politicians from both parties. in recent weeks, advocates mounted a major public pressure campaign, emphasizing the dire need for new and effective treatments for veterans and the millions of people affected by ptsd. many in the psychedelics industry had viewed this as a pivotal moment. the fda decision on mdma could be seen as a bellwether for other drugs that are in the pipeline like psilocybin and lsd, which are both considered “classic psychedelics” unlike mdma. but dr. mason marks believes the fda’s decision doesn’t spell trouble for the broader field because the agency has signaled repeatedly it’s open to psychedelic research. “i think this is a unique case,” says marks, a law professor and senior fellow with the project on psychedelics law and regulation at harvard law school's petrie flom center. “i don't think there's any sign that progress is going to be slowed. if anything, it might intensify because the other companies might see an opportunity to really get in there and compete,” he says. the wave of enthusiasm around mdma's therapeutic potential has come from research scientists at top academic centers and even the department of veterans affairs. supporters of the drug were dismayed by friday's decision. “the fda’s decision is disgraceful,” said heroic hearts project, a veterans organization that had lobbied for fda approval citing the many veteran suicides in a statement. “this is the epitome of bureaucratic red tape   and the result is people will keep dying.” opposition to the lykos’ application had gained momentum in recent months, culminating in a contentious public meeting when advisors to the fda voted against the evidence backing the treatment, largely based on concerns about shortcomings in the clinical research. in its press release, lykos said the fda echoed the issues raised by the committee. the committee's downvote put the fda in a tricky spot, given that it historically sides with the advisors. “as discussed at the advisory committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication,” an fda spokesperson said to npr in an email. “we will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.” those hoping to see mdma make it to market argue that concerns about the quality of the research were overblown and, in some cases, focused on issues with the study design that weren’t unique to mdma. the trials “undoubtedly had problems,” says stanford's heifets, but the fda could have dealt with those concerns by approving the treatment with strict restrictions around how it’s administered and a requirement to do a post market study. he worries the decision to deny approval will stifle innovation and funding into other novel treatments, including mdma like drugs that are being developed. “the fda has gone against advisory committee advice [in the past]. it has approved drugs with abuse potential,” says heifets. “none of this is that radical, so i think they could have done something else here.” on the other hand, marks says that approval would have required the fda to “pile on” so many restrictions because of concerns about the lykos’ application that ultimately it would have been “impractical” for the treatment to reach many people. he also wonders whether the all out publicity blitz by lykos and its allies was, in the end, “counterproductive” because it put the fda in an awkward position by making the decision so politicized. “this is not the end of the road for lykos,” he says, “it will cost them financially, but it doesn’t mean they can’t ultimately succeed.” the push to establish mdma assisted therapy as a legitimate treatment for ptsd stretches back two decades. researchers affiliated with the nonprofit multidisciplinary association for psychedelic studies, or maps, pioneered the early studies and developed the therapy protocol embedded in the treatment. that work ultimately set the stage for the drugmaker, which was incubated by maps, to press forward with larger human trials and seek approval from federal regulators. lykos has raised more than $100 million in anticipation of fda approval of its mdma therapy. optimism around the treatment largely stems from the company’s promising phase 3 clinical trials, which together enrolled about 200 people. the most recent one, published last year, showed just over 70% of participants no longer met the diagnostics criteria for ptsd after three therapy sessions with mdma, compared to about 48% who had the same talk therapy protocol but took a placebo. follow up research from the company showed participants were still benefiting from the treatment at least half a year after their last dosing session. “although disappointing, this move by the fda highlights the importance of conducting rigorous research into the safety and efficacy of mdma assisted therapy,” says alan davis, director of the center for psychedelic drug research and education at the ohio state university, “despite this setback, i am hopeful that there will be a better outcome down the road after more research is completed in the coming years.” debate over the merits of the lykos’ application has become increasingly divisive, with allegations that misconduct and bias in the clinical trials compromised the findings and undermined its safety. the drugmaker and many of the therapists involved in the research have steadfastly denied those claims. it’s unclear to what extent any of this factored into the fda’s deliberation on the therapy. in response to friday’s decision, emerson reiterated the company’s plan to push the research forward, saying they’d “work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients.” given what’s required to conduct another trial, heifets believes psilocybin is now poised to gain approval ahead of mdma. sponsor message become an npr sponsor

thank you for visiting nature.com. you are using a browser version with limited support for css. to obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in internet explorer). in the meantime, to ensure continued support, we are displaying the site without styles and javascript. you can also search for this author in pubmed google scholar in a decision that shocked some observers, key advisers to the us food and drug administration (fda) voted that the effectiveness of the party drug mdma for treating post traumatic stress disorder is unproven. access nature and 54 other nature portfolio journals get nature+, our best value online access subscription $29.99 / 30 days cancel any time receive 51 print issues and online access $199.00 per year only $3.90 per issue rent or buy this article prices vary by article type from$1.95 to$39.95 prices may be subject to local taxes which are calculated during checkout doi: https://doi.org/10.1038/d41586 024 01622 3 mitchell, j. m. et al. nature med. 27, 1025 1033 (2021). article pubmed google scholar mitchell, j. m. et al. nature med. 29, 2473 2480 (2023). article pubmed google scholar download references reprints and permissions psychedelic drug mdma moves closer to us approval following success in ptsd trial australia to prescribe mdma and psilocybin for ptsd and depression in world first us could soon approve mdma therapy   opening an era of psychedelic medicine psychedelic treatments are speeding towards approval   but no one knows how they work how the brain suppresses fear: mouse study offers path to anxiety treatments news 06 feb 25 engineered nose bacteria sneak drugs into the brain news 06 feb 25 are the internet and ai affecting our memory? what the science says news feature 05 feb 25 engineered nose bacteria sneak drugs into the brain news 06 feb 25 superkiller complex problems expose a cancer cell vulnerability news & views 05 feb 25 runx2 promotes fibrosis via an alveolar to pathological fibroblast transition article 05 feb 25 how the brain suppresses fear: mouse study offers path to anxiety treatments news 06 feb 25 genomics yields biological and phenotypic insights into bipolar disorder article 22 jan 25 harsh criticism and unreasonable expectations worsen phd students’ mental health career news 14 jan 25 discovery of cellular and molecular mechanisms of tissue repair and regeneration. beijing, china the chinese institutes for medical research (cimr), beijing applications are sought for an assistant professor of bioengineering for the circular bio economy within the college of engineering and architecture dublin, leinster (ie) university college dublin applications are sought for an assistant professor of artificial intelligence in food engineering within the college of engineering and architecture. dublin, leinster (ie) university college dublin the moslehi lab is recruiting highly motivated candidates for a three year post doctoral fellowship san francisco, california ucsf   moslehi lab job title: associate or senior editor, nature health location(s): new york or shanghai   hybrid working application deadline: february 14, 2025 a... new york city, new york (us) springer nature ltd psychedelic drug mdma moves closer to us approval following success in ptsd trial australia to prescribe mdma and psilocybin for ptsd and depression in world first us could soon approve mdma therapy   opening an era of psychedelic medicine psychedelic treatments are speeding towards approval   but no one knows how they work an essential round up of science news, opinion and analysis, delivered to your inbox every weekday. sign up for the nature briefing newsletter   what matters in science, free to your inbox daily. nature (nature) issn 1476 4687 (online) issn 0028 0836 (print) © 2025 springer nature limited
supported by an f.d.a. advisory panel dealt a setback to those seeking treatment for ptsd, citing health risks of the illegal drug and study flaws. by andrew jacobs the food and drug administration is weighing whether to approve the use of mdma, also known as ecstasy, for treatment of post traumatic stress disorder. but the agency’s independent advisory panel of experts reviewed studies on june 4, and overwhelmingly decided against endorsing the treatment. although not required, the f.d.a. often follows the recommendations of its advisory committees. a final decision is expected in mid august. lykos therapeutics submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of mdma and talk therapy. millions of americans suffer from ptsd, including military veterans who are at high risk of suicide. no new treatment for ptsd has been approved in more than 20 years. methylenedioxymethamphetamine (mdma) is a synthetic psychoactive drug first developed by merck in 1912. after being resynthesized in the mid 1970s by alexander shulgin, a psychedelic chemist in the bay area, mdma gained popularity among therapists. early research suggested significant therapeutic potential for a number of mental health conditions. mdma is an entactogen, or empathogen, that fosters self awareness, feelings of empathy and social connectedness. it is not a classic psychedelic like lsd or psilocybin, drugs that can cause altered realities and hallucinations. among recreational users, mdma is commonly known as molly or ecstasy.

 follow: the us food and drug administration has declined to approve an application for the use of mdma, commonly known as ecstasy, as a treatment for post traumatic stress disorder, according to a news release from drug sponsor lykos therapeutics. the company says the agency has requested an “additional phase 3 trial to further study the safety and efficacy” of the treatment. related article with fda decision looming, bipartisan group of lawmakers urge support for mdma to treat ptsd the initial application from lykos presented positive data from two late stage clinical trials that used mdma in combination with talk therapy to treat ptsd. about 200 people participated in the lykos trials, with a treatment program that involved three eight hour sessions in which they took mdma in the presence of two therapists. the mdma sessions were spaced about a month apart, along with additional talk therapy sessions.