FDA Rejects MDMA as Treatment for PTSD, Sparking Controversy
The U.S. Food and Drug Administration (FDA) made a controversial announcement on Friday, rejecting MDMA as a treatment for post-traumatic stress disorder (PTSD). The decision was based on “significant limitations” that prevent the agency from concluding that the drug is safe and effective for the proposed indication.
MDMA, also known as ecstasy or molly, is a psychedelic drug with effects similar to methamphetamine. Despite hopes from veteran organizations advocating for psychedelic-assisted therapies in treating mental health challenges, the FDA’s rejection has left many disappointed.
The decision comes after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD. The FDA has requested another Phase 3 trial to confirm the drug’s safety and efficacy.
Lykos Therapeutics, the California company that filed the drug application, plans to appeal the decision and meet with the FDA. CEO Amy Emerson expressed disappointment, stating that millions of Americans with PTSD have not seen any new treatment options in over two decades.
In response to the decision, an FDA spokesperson highlighted the limitations in the data contained in the application, preventing the agency from concluding the drug’s safety and effectiveness for PTSD treatment. The agency encourages further research and development for innovative treatments.
PharmAla Biotech, a Toronto-based company researching novel derivatives of MDMA, expressed understanding of the FDA’s responsibility while emphasizing the vital need for novel PTSD treatments. CEO Nicholas Kadysh stated the company’s commitment to ongoing research to prove the medicine’s safety and effectiveness.
Joe Perekupka, CEO of Freespira, a Washington-based company with an FDA-approved digital therapeutic for PTSD and anxiety, supported the FDA’s commitment to patient safety in reviewing potential new treatments.
The rejection of MDMA as a treatment for PTSD has sparked debate and disappointment among those advocating for innovative mental health treatments. The future of psychedelic-assisted therapies remains uncertain as companies and organizations continue to push for alternative treatment options.
