The FDA declined to approve a treatment combining the psychedelic drug midomafetamine with assisted therapy for PTSD. The agency issued a complete response letter requesting additional study and an additional Phase 3 trial to further study the safety and efficacy of the treatment. This decision comes after an advisory panel voted against approval due to insufficient evidence of efficacy. The rejection is disappointing for Lykos Therapeutics, which sought approval based on two pivotal trials. Approximately 13 million US adults have PTSD, and several veterans groups supported the treatment. The therapy was designated a breakthrough therapy in 2017 and put on a fast track for approval.
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FDA Declines Approval of MDMA-Assisted Therapy for PTSD
