It will treat lennox-gastaut, and another form of epilepsy called dravet syndrome.
An advisory panel to the FDA recommended in April that the drug be approved.
Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. They’re defined as substances with high abuse potential and “no now accepted medical use”. They’re not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely.
The European Medicines Agency is expected to rule on the therapy in early 2019.
And Epidiolex’s approval doesn’t mean other CBD substances are OK to sell, Gottlieb said.
The DEA did not immediately respond to Ars’ request for comment.
GW said it expects the reclassifying to occur within 90 days.
“And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition”, he continued.
A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD. But six years ago, she started giving him oil, potent with CBD, made from a strain of marijuana grown in Teller County by the Stanley brothers.
“This is clearly a breakthrough drug for an very bad disease”, John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug. Patel said the drug trials generated good information about safety and side effects of CBD use, and the FDA approval opens doors for more research on the benefits and effectiveness of CBD on other conditions.
One recent study into CBD found that a significant number of products didn’t contain the amount of CBD that they claimed to on the label.
“Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases”, he said.
On a call with reporters on Monday, FDA Commissioner Scott Gottlieb, M.D., cautioned that Epidiolex’s green light is not an approval for marijuana but an approval for “one specific CBD medication for a specific use” based on well-controlled clinical trials. “And, the FDA is committed to this kind of careful scientific research and drug development”.