FDA criticism of MDMA-assisted therapy is an opportunity for psychedelic medicine

MDMA-assisted therapy faces FDA scrutiny, but the FDA criticism is framed as an opportunity for psychedelic medicine to mature scientifically. The piece centers on the FDA issuing a complete response letter to Lykos Therapeutics, denying approval for MDMA-assisted therapy for PTSD, and pointing to ongoing issues tied to the earlier FDA Advisory Committee discussion about whether the product is approvable. The argument emphasizes that psychedelic therapies must meet the same evidentiary and safety standards as other drugs, and that sponsors are responsible for producing well-designed trials with data adequate to characterize benefit and risk. It also references FDA draft guidance for psychedelic drugs that aims to clarify expectations for clinical investigations.