Psychedelic drug MDMA rejected as treatment for PTSD despite veterans’ support

Psychedelic drug MDMA rejected as treatment for PTSD despite veterans’ support Show Caption Hide Caption FDA panel rejects the use of psychedelic drug MDMA for PTSD treatment A panel of advisers to the FDA has voted against the use of MDMA to treat patients with post-traumatic stress disorder, citing flawed studies and the risk of abuse. Scripps News The Food and Drug Administration on Friday rejected a California drug company’s request to market the psychedelic drug MDMA combined with talk therapy as a treatment for post-traumatic stress disorder. The federal drug regulator told San Jose, California-based Lykos Therapeutics it completed a review of the company’s application but would not approve MDMA, also known as ecstasy or molly, as a treatment for PTSD. The decision was closely watched by academics, private companies and investors who’ve poured millions into efforts to develop psychedelic drugs as mental health treatments. The company’s application, granted priority review by the FDA, had been championed by military veterans desperate for a new treatment for post-traumatic stress disorder amid stubbornly high suicide rates. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Amy Emerson, CEO of Lykos Therapeutics. In June, the FDA’s Psychopharmacologic Drugs Advisory Committeevoted 9-2 against MDMA as an effective treatment for PTSD patients, and 10-1 that the drug’s benefits do not outweigh the risks. During the advisory panel’s discussion, members acknowledged the need for a new PTSD treatment but raised questions about the company’s data and study design. Emerson said the company thinks many of the issues raised by the FDA and its advisory committee “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.” Earlier studies showed about 86% of participants who received the MDMA treatment along with therapy reported reduced PTSD symptoms, and 71% improved to such a degree they no longer met the diagnostic criteria for PTSD. In the letter, the Bergman and other House members said the FDA hasn’t approved a new treatment for PTSD in 25 years. – This Summarize was created by Neural News AI (V1). Source: https://www.usatoday.com/story/news/health/2024/08/09/fda-rejects-mdma-for-ptsd/74673858007/