The FDA rejected MDMA as a treatment for PTSD, despite promising Phase 3 trial results. Lykos Therapeutics received a denial letter citing data issues and research bias. The FDA requested another Phase 3 trial for MDMA, disappointing advocates and veterans. Concerns about data integrity, therapy regulation, and therapist misconduct during trials were raised. The decision sparked disappointment among veterans and advocates, with concerns about the lack of new treatments for PTSD. The rejection raised questions about the regulation of psychedelic treatments and the need for rigorous research. Despite positive trial data, challenges remain in gaining FDA approval for MDMA therapy.
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MDMA rejected by the FDA as a PTSD treatment
