Below is a reprint of a major news release from MAPS, an organization that was solely responsible for the FDA MDMA-Assisted Therapy research.
2024 is shaping up to be a huge year on all fronts. It feels like the world is shifting to a new state, and that the events of 2024 might determine the direction of the shift. On the one hand, the US elections, the two major wars, the deepening economic divide combined with shaky economic news, and the deepening environmental crisis understandably make everyone nervous. On the other hand, there’s major progress in nuclear fusion technology that promises an endless supply of clean energy, and of course, there’s the impending medical legalization of the first psychedelic therapy, MDMA-Assisted Therapy, which might mark a revolution in mental health and well being, changing the way we heal and relate.
Below is a reprint of a major news release from MAPS, an organization that was solely responsible for the FDA MDMA-Assisted Therapy research.
Announcement: MAPS Congratulates Lykos Therapeutics on Acceptance of New Drug Application for MDMA-Assisted Therapy for PTSD
February 9, 2024
The FDA has accepted a New Drug Application filed by Lykos Therapeutics for MDMA-assisted therapy for PTSD
The application was supported by clinical trial data collected over nearly two decades of research incubated by MAPS
The FDA granted the application Priority Review and is expected to announce its determination in August 2024
The Multidisciplinary Association for Psychedelic Studies (MAPS) congratulates Lykos Therapeutics, formerly MAPS Public Benefit Corporation, on its announcement that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for midomafetamine capsules used in combination with psychological intervention for individuals with PTSD. The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024 to make the review determination.
“Thirty-eight years ago, one of my primary motivations for founding MAPS was to carve a path for psychedelic-assisted therapies to become FDA-approved treatments. Today, with the notification that the FDA will evaluate MDMA-assisted therapy for PTSD for potential approval as early as August 2024, and backed by decades of research incubated by MAPS, we are celebrating the therapists and subjects who participated in the Phase 2 and Phase 3 studies and the team at Lykos Therapeutics on the historic accomplishment they have achieved. We hope that potential FDA approval of MDMA-assisted therapy for PTSD is only the first of many psychedelic-assisted therapies that become available by prescription.”
-Rick Doblin, Ph.D., Founder and President, MAPS
Link to the announcement:
Visit the Enhanced Therapy Podcast: Conversations with Experts in MDMA-Assisted Therapy:
https://enhancedtherapy.ca/enhanced-therapy-podcast/
- Note that MDMA is illegal and MDMA-Assisted Therapy is not approved for any use at this time. We do now encourage or condone the use of MDMA in any context.
