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MDMA-assisted Therapy for PTSD

For almost two decades, MAPS (The Multidisciplinary Association for Psychedelic Studies) has been conducting FDA-regulated drug development research into MDMA-assisted therapy for PTSD in the United States, Switzerland, Israel, and Canada. We have completed Phase 1 and Phase 2 studies and the first of two Phase 3 studies, with very promising results.  We’re also starting research in five countries in Europe and England for approval by the European Medicines Agency in England, Netherlands, Portugal, Germany, the Czech Republic, and Norway. The FDA has awarded Breakthrough Therapy designation to MDMA-assisted Therapy for PTSD. This evening will address the history of MDMA, our safety and efficacy data, information about mechanisms of action and our therapeutic approach, and possible post-approval regulations. We currently anticipate FDA approval around the end of 2022 or early 2023. Approval in Europe would be a year or so later, depending on the availability of funding.

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Rick Doblin, Ph.D., Michael Mithoefer, MD and Annie Mithoefer, BSN