MDMA for PTSD: Three studies retracted on heels of FDA rejection

Enlarge / MDMA (credit: Getty | PYMCA/Avalon)

A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after news broke that the Food and Drug Administration rejected the treatment, despite positive results reported from two Phase III clinical trials.

On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA. Lykos said the letter echoed the numerous concerns raised previously by the agency and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy. The FDA and its advisors identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of psychedelics. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).

FDA advisors also noted the public allegations of a sexual assault of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.