Ecstasy’s Rebuff as PTSD Drug Exposes Flawed Process at FDA (1)

A federal panel’s near-unanimous opposition to an MDMA-based therapy for post-traumatic stress disorder exposed deep flaws in regulators’ handling of psychedelic drugs.

Supporters had hoped a positive outcome for Lykos Therapeutics Inc.’s treatment for post-traumatic stress disorder would advance efforts to legalize psychedelics for medical use. Instead, a committee of outside experts convened by the US Food and Drug Administration to review the treatment had sharp criticism about the study design approved by FDA, calling into question the agency’s credibility and whether it will be ready to green-light any psychedelic drugs in the near future.

“The committee rightly identified a ...