FDA Panel Rejects MDMA-Based PTSD Treatment

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In a setback for the emerging field of psychedelic therapies, a U.S. Food and Drug Administration advisory panel voted against approving an MDMA-based treatment for post-traumatic stress disorder (PTSD). The panel expressed concerns about the trial design, data collection, and potential risks associated with the drug, commonly known as ecstasy. Jessica Reyes and Patricia Wu discuss the story with psychologist, Dr. Catherine Bailey.

Setback for MDMA therapy

While advocates have long championed MDMA’s therapeutic potential, the panel determined that the available evidence did not sufficiently demonstrate the treatment’s effectiveness in PTSD patients. Concerns were also raised about inappropriate therapist behavior in a mid-stage study and the lack of documentation of abuse-related adverse events.

The urgency for effective PTSD treatment

Despite these concerns, more than 190 patients who received MDMA alongside therapy showed a significant reduction in PTSD scores compared to those receiving a placebo. Lykos Therapeutics, the maker of the MDMA capsule, expressed disappointment in the vote, citing the urgent need for effective PTSD treatments.

Dr. Bailey’s takeaways

Dr. Baily acknowledges that the FDA’s decision comes as a disappointment to many, she believes that the panel professionally acted with due diligence. While the FDA isn’t required to follow the panel’s decision, it usually does, with a final decision most likely being announced in August. It’s possible that new findings could lead to a different decision in the Future, but Dr. Bailey recognizes that the panel could not, in good conscience, approve the treatment at this time.

Editorial Team
Editorial Team
At the heart of MHTN - America's pioneering 24/7 Mental Health TV Network - is our editorial team, a dynamic group of professionals united by a shared commitment to transforming the conversation around mental health. Our team is composed of seasoned journalists, mental health experts, researchers, and storytellers, each bringing a wealth of experience and a passion for advocacy.

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