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In September, the Food and Drug Administration released its recent complete response letter (CRL) to Lykos Therapeutics, denying approval for MDMA-assisted therapy for post-traumatic stress disorder. It confirmed the issues raised at the 2024 FDA Advisory Committee meeting regarding the approvability of MDMA. When the non-approval was announced in 2024, critics called it the end of psychedelic medicine. Advocates blamed regulatory roadblocks. I’m a proponent of psychedelic research and to me, it marked the beginning of our scientific journey to prove the potential treatment benefit of psychedelics. The FDA isn’t shutting down psychedelic medicine. It’s asking this emerging field to meet the same scientific standards as any other drug. In fact, the FDA issued the 2023 draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations” to help sponsors design clinical trials to meet FDA standards. Advertisement Lykos’ application had challenges that would have compromised any drug candidate, psychedelic or otherwise. The FDA’s mandate is to protect public health. It is the responsibility of the research sponsor to conduct well-designed and well-executed trials that deliver reliable data that can adequately characterize the benefit and risk profiles of a drug. Prescribers and patients rely on this data to make informed decisions about whether they should use a drug.
