MAPS Celebrates Submission of New Drug Application to FDA for MDMA-Assisted Therapy for PTSD

  • MAPS incubated the program that generated the first NDA submission for any psychedelic-assisted therapy
  • Submission represents 30-plus years of philanthropy-driven clinical research into potential use of MDMA-assisted therapy for PTSD
  • If accepted for review by the FDA, the application could be approved next year

SAN JOSE, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- MAPS Public Benefit Corporation (MAPS PBC) formally submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) which included data from two published Phase 3 studies as well as numerous earlier trials. The nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) created MAPS PBC in 2014 to advance the research and drug development program for investigational MDMA-assisted therapy for PTSD.

When I started MAPS in 1986, the FDA was still blocking all research with psychedelics. MAPS had to try, though we might never succeed, to gather sufficient data about the safety and efficacy of MDMA-assisted therapy to seek approval for prescription use. As it has turned out, it took 37 ½ years to gather the necessary data to seek approval! All the effort and time have been totally worth it for the progress that we have seen in our research and the millions of people we hope to help through the public-benefit pharmaceutical model if FDA does approve the treatment.

By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.
Rick Doblin, Ph.D., MAPS’ Founder and President

The Phase 3 clinical trials and NDA submission were funded in part through multiple fundraising campaigns spearheaded by a challenge grant from Tim Ferriss and the Saisei Foundation and including grants from the Steven & Alexandra Cohen Foundation. Thousands of additional generous supporters, detailed here, joined us in this visionary quest.

View Additional Information from MAPS PBC

The safety and efficacy of psychedelic-assisted therapies 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.

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 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.


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