Patients were randomized 2:1 to fostamatinib (100 mg orally twice daily) or placebo twice daily for 24 weeks. Dose could be escalated to 150 mg orally twice daily after one month. The benefit of fostamatinib was assessed based on the percentage of participants who achieved and maintained the pre-determined platelet count between treatment weeks 14 to 24 in fostamatinib and placebo groups respectively. The FIT-1 trial was conducted at 35 sites in Australia, Canada, Denmark, Hungary, Italy, Netherlands, the United Kingdom, and the United States. The FIT-2 trial was conducted at 23 sites in Austria, Bulgaria, Czech Republic, Germany, Norway, Poland, Romania, and Spain.The FDA granted the application for fostamatinib an orphan drug designation and granted the approval of Tavalisse to Rigel Pharmaceuticals.Fostamatinib was approved for medical use in the European Union in January 2020. References
External links
"Fostamatinib". Drug Information Portal. U.S. National Library of Medicine. "Fostamatinib disodium". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02076399 for "A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP) (FIT)" at ClinicalTrials.gov
Alfentanil (R-39209, trade name Alfenta, Rapifen in Australia) is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around one-fourth to one-tenth the potency, one-third the duration of action, and an onset of action four times faster than that of fentanyl. Alfentanil has a pKa of approximately 6.5, which leads to a very high proportion of the drug being uncharged at physiologic pH, a characteristic responsible for its rapid onset. It is an agonist at mu opioid receptors. While alfentanil tends to cause fewer cardiovascular complications than other similar drugs such as fentanyl and remifentanil, it tends to give stronger respiratory depression and so requires careful monitoring of breathing and vital signs. Almost exclusively used by anesthesia providers during portions of a case where quick, fast-acting (though not long-lasting) pain control is needed (as, for example, during nerve blocks), alfentanil is administered by the parenteral (injected) route for fast onset and precise control of dosage. Discovered at Janssen Pharmaceutica in 1976, alfentanil is classified as a Schedule II drug in the United States.Side effects of fentanyl analogs are similar to those of fentanyl itself and include itching, nausea and potentially life-threatening respiratory depression. Fentanyl analogs have killed hundreds of people throughout Europe and the former Soviet republics since the most recent resurgence in use began in Estonia in the early 2000s, and novel derivatives continue to appear. References
External links
Medline Plus Patient Information - 09/01/2010
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm February 2017
Genf interaction table- https://www.hug.ch/sites/interhug/files/structures/pharmacologie_et_toxicologie_cliniques/carte_cytochromes_2016_final.pdf February 2017