MAPS PBC Publishes Results of Successful Confirmatory Phase 3 Trial of MDMA-Assisted Therapy for PTSD

FOR IMMEDIATE RELEASE: September 14, 2023

  • Nature Medicine has published the peer-reviewed results of MAPP2, the second Phase 3 trial of MDMA-assisted therapy for PTSD
  • The MAPS-sponsored, philanthropy-funded study met primary and secondary endpoints confirming the first Phase 3 study findings
  • MAPS PBC expects to file the New Drug Application with the U.S. Food and Drug Administration in 2023

Results of the second, confirmatory Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder, MAPP2, have been published in Nature Medicine. MAPP2 was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and administered by MAPS Public Benefit Corporation (MAPS PBC), a subsidiary of MAPS. MAPS PBC is compiling data from 18 MAPS-sponsored Phase 2 and Phase 3 studies to form the basis of the New Drug Application, expected to be filed with the FDA later this year. 

Thanks to the combined efforts of dozens of therapists, hundreds of participants who volunteered in MAPS-sponsored trials, and many thousands of generous donors, MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024. Nature Medicine has published the results of the second MAPS-sponsored Phase 3 trial of MDMA-assisted therapy for PTSD, confirming our prior results. We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year — and that our Open Science, Open Books principle will inspire researchers to make this just the first of many psychedelic-assisted therapies to be validated through diligent research.

Rick Doblin, PhD, MAPS Founder and President

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NOTE
The safety and efficacy of all psychedelic-assisted therapies, including MDMA-assisted therapy, are currently under investigation. No psychedelic-assisted therapy has been approved by the FDA or other regulatory authorities; no therapy works for everyone; and all therapies, even in clinical settings, carry risks.

ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world through its wholly-owned subsidiaries MAPS PBC and MAPS EU. Since MAPS was founded, philanthropic donors and grantors have given more than $140 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.