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June 05, 2024

FDA advisory panel votes against MDMA for treatment of PTSD

Concerns about the safety of the psychedelic drug and the way studies were conducted led to the decision.

Mental Health Psychedelics

An FDA advisory panel rejected MDMA-assisted therapy for the treatment of PTSD. MDMA, shown in pill-form here, has psychedelic effects that research suggests may help alleviate the intense anxiety and other symptoms of PTSD.

An advisory board for the U.S. Food and Drug Administration has rejected a proposal to approve MDMA – a psychedelic drug known popularly as ecstasy or "molly" – for the treatment of post-traumatic stress disorder.

"Participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms," the FDA panel wrote in a brief about studies submitted by Lykos Therapeutics, the drug's sponsors. But the panel also said there were "several factors" that made "these data challenging to interpret and complicate the benefit-risk assessment for this application."

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The panel cited concerns about the drug's safety and the lack of diversity in the study group. The panel also indicated that people in the control group – study participants who did not receive MDMA – probably could tell they were not getting the drug because of its known hallucinogenic effects. That may have impacted the integrity of the research.

MDMA is one of several psychedelic drugs that are poised to come before the FDA, including psilocybin and LSD, for the treatment of mental health issues.

About 200 people participated in the trials involving three, eight-hour sessions. Study participants took MDMA in the presence of two therapists.

The FDA is not bound by the advisory panel's decision and will make a final ruling in August. The approval of MDMA-assisted therapy would be the first new treatment for PTSD in nearly 20 years.

Zoloft and Effexor are the only two FDA-approved medications for PTSD, although people who suffer from it also frequently take serotonin reuptake inhibitors, also referred to as SSRIs. People with PTSD, who often experience severe anxiety, flashbacks and nightmares, also may receive forms of psychotherapy and behavioral therapy.

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