FDA advisers consider MDMA therapy to treat PTSD

A federal advisory committee meets today to weigh the risks and benefits of using MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder.

A federal advisory committee meets today to weigh the risks and benefits of using MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder. MDMA is classified as a schedule I drug under the Controlled Substances Act, and approving it would be a marked shift. It’s the first time the FDA’s advisers have considered a psychedelic drug for medical use. The novel treatment has the potential to transform a field with significant need, but critical questions loom. About 5% of adults in the United States – about 13 million people – experience PTSD in any given year, according estimates from the National Center for PTSD. But current treatment options – including antidepressants and some specialized forms of cognitive behavioral therapy – are limited in their scope and effectiveness, with few alternatives available to help those don’t respond well to them. Lykos Therapeutics has promising data from two late-stage clinical trials that used MDMA in combination with therapy to treat PTSD. MDMA is a psychedelic drug known as an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness and emotional openness. About 200 people participated in the Lykos trials, with a treatment program that involved three eight-hour sessions where participants took MDMA in the presence of two therapists. The MDMA sessions were spaced about a month apart, along with additional therapy sessions. “Participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms,” the US Food and Drug Administration wrote in a briefing document about the studies.