MAPS FDA request

NEWS: MAPS Submits Request for MDMA-Assisted Therapy Approval

The Multidisciplinary Association for Psychedelic Studies (MAPS) has formally submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval for the use of MDMA, commonly known as ecstasy, as a therapy for PTSD.

This marks an unprecedented move as it’s the first time such an application has been made for a psychedelic-assisted treatment. The submission is backed by comprehensive data from two pivotal ‘Phase 3’ studies and a substantial body of earlier trials, representing over three decades of research into the potential efficacy of MDMA-assisted therapy for PTSD. This development underscores a tangible advancement in the exploration of alternative treatment modalities for PTSD.

MAPS Public Benefit Corporation (MAPS PBC), established in 2014 by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has been at the forefront of steering the research and drug development program for MDMA-assisted therapy.

Dr. Rick Doblin, Founder and President of MAPS, reflected on the historical significance of this milestone, stating, ” 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.”

If accepted for review by the FDA, approval for this innovative PTSD treatment could potentially be granted as early as next year. This development not only signals hope for people with PTSD but also demonstrates a huge potential leap forward in the landscape of PTSD research which will also be bolstered by Australian physicians who already have the authority to prescribe MDMA, to people with PTSD.

For detailed insights and further information, please refer to the official release from MAPS here.

 


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 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.


NOTE

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.

Sources

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