MAPS report successful outcome of their first phase 3 trial of MDMA-assisted therapy for PTSD

Rick Doblin, writing on the MAPS website, reports: "It’s now with an enormous sense of pride, satisfaction, and relief that I can share that we learned that MAPP1 was statistically significant, and is therefore considered a successful Phase 3 study. MAPS is on track towards our goal of obtaining FDA approval if we can successfully complete our second Phase 3 study and other associated safety studies that the FDA has required. We now can say with certainty that the $30 million recently raised by MAPS, the Psychedelic Science Funders Collaborative (PSFC), author Tim Ferriss, and all other donors in our Capstone Campaign will be sufficient to generate all of the research data we need prior to submitting an NDA to the FDA, and then to Health Canada and the Israeli Ministry of Health. In order to bring the therapeutic potential of MDMA-assisted psychotherapy for PTSD to the estimated 350 million people around the world who suffer from PTSD, MAPS is now launching a new $30 million campaign to raise the funds necessary to conduct Phase 3 research in Europe for approval by the European Medicines Agency (EMA) and to globalize regulatory approval in many countries of the world. 

While the therapeutic use of MDMA was pioneered around 1976 by Leo Zeff, Ph.D. (a.k.a. The Secret Chief), and I have known since 1984 that MDMA-assisted psychotherapy was excellent at treating PTSD when I used this modality with someone suffering from PTSD , it’s only now in 2020 that we have been able to generate evidence supporting safety and efficacy in the context of an FDA-regulated Phase 3 clinical trial. It’s tragic that so much suffering could have been avoided since 1986 when the Drug Enforcement Administration (DEA) rejected the recommendation of the DEA Administrative Law Judge that the therapeutic use of MDMA-assisted psychotherapy remain legal. Our current timetable for the potential of FDA approval is the first half of 2023, 37 years after the DEA kept both the therapeutic and social use of MDMA illegal. 

We believe that potential FDA approval of MDMA-assisted psychotherapy for PTSD will be followed by regulatory approvals around the world. This will be followed by the establishment of thousands of psychedelic clinics with therapists cross-trained to provide therapy assisted by MDMA and other psychedelics, including ketamine and psilocybin, as other sponsors obtain approval from regulators. Eventually, in a post-prohibition world, there could be a licensed regulatory system for adults to legally access psychedelics to take on their own without supervision by therapists with access to minors only with permission from their parents or guardians."