Is the Phase 3 Trial Data for MDMA Therapy sets Path for FDA Approval?

The first results from Phase 3 trials testing MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) have been announced. The extremely promising data are the first Phase 3 results to be revealed for any psychedelic-based therapy, paving the way for a landmark US Food and Drug Administration (FDA) approval in 2023.

While you are likely to have come across a multitude of news articles touting the current psychedelic renaissance, the reality is the science is still incredibly nascent, and most human trials to date have been conducted in very small cohorts. Perhaps the biggest psychedelic science milestone in 2021 came with the first published data from a Phase 3 clinical trial testing MDMA-assisted psychotherapy for PTSD.

The impressive data paves the way for full market approval from the US Food and Drug Administration (FDA). However, the conservative regulatory body is holding off approval until the results of a second Phase 3 trial are delivered, meaning the first fully legal psychedelic medicine is unlikely to reach public clinics before 2023.

For decades the Multidisciplinary Association of Psychedelic Studies (MAPS) has been working on establishing MDMA-assisted psychotherapy as a novel treatment for severe PTSD. Out of all the research going on in the psychedelic renaissance, from psilocybin for depression to LSD for pain, these MDMA studies have always been at the front of the pack.

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