Treatment · United States

FDA rejects MDMA-assisted therapy for PTSD, citing trial-design concerns

Lykos Therapeutics' application, the first psychedelic to seek formal FDA approval, was turned back over methodology, not biology.

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Army Times (AP)Silver Spring, MDAugust 9, 20246 min read

Federal regulators declined to approve Lykos Therapeutics' MDMA-assisted therapy for post-traumatic stress disorder, a major setback for the psychedelic research field and the veterans' groups who had pushed hardest for it. The FDA pointed to functional unblinding, allegations of misconduct at trial sites, and missing long-term safety data.

The decision does not say MDMA does not work; it says the evidence package, as submitted, was not good enough. Lykos was asked to run an additional Phase 3 trial. The ruling is likely to shape how every other psychedelic sponsor (for psilocybin, ibogaine and LSD) designs its pivotal studies.

Read the AP report at Army Times for the full FDA rationale and reactions from the veterans community.

Read the original at Army Times (AP)

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