FDA panel rejects MDMA therapy for PTSD

Jun 25, 2024

On June 4, a panel of U.S. Food and Drug Administration (FDA) advisors voted against recommending MDMA-assisted therapy as a treatment for post-traumatic stress disorder (PTSD).  The panel examined the results from two clinical trials carried out by Lykos Therapeutics presented at a public meeting which demonstrated that MDMA-assisted therapy improved symptoms of PTSD over 18 weeks of treatment. Moreover, the study results also showed that these improvements lasted for several months after the treatment period ended.

The study results showed that 67% of participants taking MDMA no longer met the diagnostic criteria for PTSD after 18 weeks, compared to 33% of the placebo group. Moreover, 33% of participants treated with MDMA were determined to be in PTSD remission after three sessions, compared to 5% of participants in the placebo group.

However, the FDA advisors concluded that the available evidence fails to show that MDMA is effective for the treatment of post-traumatic stress disorder (PTSD) or that its benefits outweigh its risks. Specifically, after public comment and discussion, the FDA panel voted 9-2 that MDMA, combined with talk therapy, is not effective for treating PTSD. 

In addition, the advisors voted 10-1 that the benefits of MDMA treatment do not outweigh its risks.

“We rely on data from adequate and well-controlled trials to provide the basis for a substantial evidence of effectiveness,” said Dr. David Millis, clinical reviewer in the division of psychiatry at the FDA, said during the panel meeting. “Among other characteristics, to be considered adequate and well-controlled, a study must incorporate a design that permits valid comparison with a control condition, and measures must be taken to minimize bias.”

MDMA, also known as “ecstasy,” is a synthetic oral drug with stimulant and hallucinogenic effects. Furthermore, in 2017, the FDA granted MDMA breakthrough therapy designation for its use together with psychotherapy to treat PTSD. Although the FDA is not required to follow the panel’s recommendations, the advisory panel has identified several significant shortcomings of the clinical research presented. These uncertainties included unanswered questions regarding the drug’s potential for abuse, and a lack of evidence supporting the psychological approach used in the therapy sessions.

The FDA also noted in its review that clinical trial participants should have been “blind” to receiving MDMA or a placebo treatment, but a survey carried out upon the FDA’s request revealed that participants mostly correctly guessed their treatment. In addition, the FDA raised concerns over the potential health risks of the drug, including adverse effects on the cardiovascular system and the liver. In addition, the FDA had also requested the company to collect reports associated with abuse, but researchers failed to capture effects such as “euphoria” or “elated mood,” in order to determine the potential risk of abuse.