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 two decades of research incubated by MAPSThe FDA granted the application Priority Review and is expected to announce its determination in August 2024
SAN JOSE, Calif., Feb. 09, 2024 (GLOBE NEWSWIRE) — 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., MAPS Founder and President
The safety and efficacy of psychedelic-assisted therapies are currently under investigation. Neither MDMA-assisted therapy for PTSD, nor any other psychedelic-assisted therapy, has been established for the treatment of any mental health condition. MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD. No treatment works for everyone; all treatments, even in clinical settings, carry risks.
Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Lykos Therapeutics, a drug-development public benefit company, and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $150 million to advance psychedelic research, change drug policy, and shape culture.