https://arstechnica.com/science/2024/08/mdma-for-ptsd-three-studies-retracted-on-heels-of-fda-rejection/ [arstechnica.com]
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 [arstechnica.com].
On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA [lykospbc.com]. Lykos said the letter echoed the numerous concerns raised previously by the agency [arstechnica.com] and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy [arstechnica.com]. The FDA and its advisers 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 advisers also noted the public allegations of a sexual assault [qz.com] of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.