It's Looking Like We'll See Federally Legal MDMA in 2024
- The FDA is expected to consider legalizing MDMA-assisted therapy for PTSD next year based on recent clinical studies.
- A recent study published in Nature Medicine found that MDMA therapy significantly reduced symptoms of moderate to severe PTSD, with 86.5% of subjects seeing a significant improvement.
- The study was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), which has been advocating for legal psychedelic therapy since 1986.
- If the FDA approves the New Drug Application, MDMA-assisted therapy could become fully legal in 2024, with licensed physicians able to dispense MDMA to PTSD patients.
The US Food and Drug Administration (FDA) is likely to consider legalizing MDMA-assisted therapy next year, based on the strength of recent clinical studies.
The newest of these studies, which was published in the Nature Medicine journal this month, found that MDMA therapy significantly reduced symptoms of moderate to severe PTSD. In this randomized double-blind trial, 104 subjects attended traditional talk therapy sessions after receiving either MDMA or a placebo. The vast majority (86.5%) of subjects who received MDMA saw a significant improvement in their symptoms. The treatment was so effective, in fact, that 71% of participants no longer even met criteria for PTSD by the end of the study.
“MDMA simultaneously induces prosocial feelings and softens responses to emotionally challenging and fearful stimuli, potentially enhancing the ability of individuals with PTSD to benefit from psychotherapy by reducing sensations of fear, threat and negative emotionality,” the study authors explained. “This confirmatory phase 3 trial showed consistent benefits of MDMA-AT in an ethnoracially diverse group of individuals with longstanding moderate to severe PTSD and numerous comorbidities. The dropout rate was low, and treatment was generally well tolerated.”
This new study was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a research group that has been advocating for legal psychedelic therapy since 1986. The nonprofit's rigorous research studies eventually convinced the FDA to grant MDMA “Breakthrough Therapy” status in 2017, which allowed MAPS to fast-track further research. Since then, the organization has sponsored 18 Phase II and III studies that have confirmed that MDMA therapy is an effective treatment for PTSD.
MAPS' first Phase III trial found that MDMA therapy provided meaningful relief from PTSD symptoms in nearly 90% of all study subjects. The latest trial was designed to confirm that those findings were no fluke, and it achieved that goal with flying colors. Now that these Phase III trials are complete, MAPS plans to file a New Drug Application with the FDA before the year is out. And if the agency approves this application, MDMA-assisted therapy would likely become fully legal in 2024. The approval would only allow licensed physicians to dispense MDMA to PTSD patients, however, and would not legalize it for any other use.
“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,” said MAPS founder and president Rick Doblin, PhD in a press release.
The feds have traditionally considered psychedelics as dangerous drugs with no medical use, but health officials seem increasingly willing to listen to science. The FDA legalized ketamine as a treatment for depression in 2019, and the heads of the FDA and NIH have separately acknowledged the therapeutic potential of psychedelics. Biden administration officials even said they were “actively exploring” the possibility of creating a federal psychedelics research task force. So there is indeed a solid chance that the FDA will agree to authorize this novel therapy.
“Nature Medicine has published the results of the second MAPS-sponsored Phase 3 trial of MDMA-assisted therapy for PTSD, confirming our prior results,” Doblin said. “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.”