The Food and Drug Administration rejected MDMA as a treatment for post-traumatic stress disorder on Friday, in a blow to drug activists and veterans who’ve long campaigned for the psychedelic treatment. Although two Phase 3 trials suggested the treatment was effective, strong opposition by an agency scientific advisory committee in June and allegations of missing adverse event data and research bias may have doomed the application by Lykos Therapeutics.
Lykos and its parent organization, MAPS, had been working for decades toward winning approval of MDMA. The company said in a statement it had received a “complete response letter” from the FDA denying its application “based on the data submitted.” It said the issues raised by the FDA echo those brought up during the ad comm meeting.
The FDA requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of MDMA, and Lykos said it will request a meeting with the FDA to ask for reconsideration of the decision.
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