FDA Panel Rejects MDMA Therapy For PTSD

The panel raised concerns about the study’s methods and failure to address previous instances of research misconduct.

Last month, the first psychedelic therapy treatment came before the Food and Drug Administration for a vote. It entailed using MDMA, also known as ecstasy or molly, to treat PTSD.

MDMA therapy has looked promising as a treatment for PTSD and other mental health conditions in some studies. But the FDA scientific advisory panel that evaluated this treatment voted overwhelmingly against approving it.

Many of the arguments against approval had less to do with MDMA itself than with the methodology of the clinical trials done by Lykos Therapeutics, formerly the Multidisciplinary Association for Psychedelic Studies, or MAPS. The FDA panel was presented with allegations of misconduct and incongruous data, including a letter by trial participant Sarah McNamee.

McNamee, who joined the trial for treatment of PTSD, is also a licensed psychotherapist and researcher of trauma and psychotherapy at McGill University in Montreal. She joins guest host Rachel Feltman alongside Dr. Eiko Fried, a methodologist and psychologist at Leiden University in the Netherlands, to discuss the decision.

If you or someone you know is struggling with PTSD or other mental health conditions, call 988 for the suicide and crisis lifeline.

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