FDA Committee to Review Data Supporting New Drug Application for MDMA for PTSD in June


This is the first FDA advisory committee meeting that will review a potential new posttraumatic stress disorder treatment in 25 years.

The FDA’s Psychopharmacologic Drugs Advisory Committee will review data supporting the new drug application (NDA) for midomafetamine (MDMA) capsules on June 4, 2024, which are being investigated for use in combination with psychological intervention for adults with posttraumatic stress disorder (PTSD). According to a press release by Lykos Therapeutics, this is the first FDA advisory committee meeting that will review a potential new PTSD treatment in 25 years.1

Posttraumatic stress disorder | Image Credit: Stepan Popov - stock.adobe.com

Image Credit: Stepan Popov - stock.adobe.com

"This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy," Amy Emerson, CEO of Lykos Therapeutics, said in a press release. "We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD."1

The Committee will review the results of the MAPP1 (NCT03537014) and MAPP2 studies, which evaluated MDMA-assisted therapy compared to the placebo and psychological interventions in individuals who have severe or moderate to severe PTSD, respectively.1

In the randomized phase 3 study (NCT04077437; MAPP2), approximately 26.9% of individuals had moderate PTSD and 73.1% had severe PTSD. The study authors reported that approximately 86.5% of individuals who were treated with MDMA-assisted therapy had clinically meaningful improvements at 18 weeks after baseline compared with 69% in the placebo group. Further, 71.2% of individuals no longer met the criteria for PTSD compared with 47.6% of individuals in the placebo group.2

Approximately 46.2% of individuals in the MDMA-assisted therapy group met remission criteria compared to 21.4% in the placebo group. Only 7 individuals reported severe treatment-emergent adverse events, with 5 occurring in the MDMA group.2

Furthermore, MAPP1 also met its primary end point and key secondary endpoints with no serious adverse events reported in the MDMA cohort, according to an article from Pharmacy Times.3

Key Takeaways

  1. The Psychopharmacologic Drugs Advisory Committee will convene on June 4, 2024, to assess data from Lykos Therapeutics' new drug application (NDA) for MDMA-assisted therapy.
  2. Lykos' Phase 3 studies (MAPP1 and MAPP2) showed significant improvement in PTSD symptoms compared to placebo. Up to 86.5% of participants in the MDMA group had clinically meaningful improvements at 18 weeks, with a substantial portion no longer meeting PTSD criteria.
  3. If approved, this would be the first FDA-approved MDMA-assisted therapy and psychedelic-assisted therapy for any condition. It would also necessitate rescheduling MDMA from its current Schedule I classification (high potential for abuse).

“I would encourage pharmacists to start reading the literature, start looking at these articles, and evaluating this because these things are coming soon, and they are quite different than the way that we've thought about other new therapeutics on the market. I think it's important for pharmacists to start thinking about what their role could be to facilitate this transition into a new paradigm of psychiatric treatment,” Kelan Thomas, PharmD, MS, associate professor of clinical sciences at Touro University California College of Pharmacy, said in a prior interview with Pharmacy Times.4

In February 2024, the FDA accepted the NDA for this indication, assigning it a prescription drug user fee act target action date of August 11, 2024. If approved, this would mark the first MDMA-assisted therapy and psychedelic assisted therapy approved and call for a rescheduling of MDMA from Schedule I, according to an article in Pharmacy Times. Further, the FDA also granted priority review to the NDA.5

  1. Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted Therapy for PTSD. News release. Lykos Therapeutics. May 6, 2024. Accessed May 8, 2024. https://news.lykospbc.com/2024-05-06-Lykos-Therapeutics-Announces-FDA-Advisory-Committee-Meeting-to-Review-Investigational-MDMA-Assisted-Therapy-for-PTSD
  2. Gallagher A. MDMA-Assisted Therapy Demonstrates Significant Reductions in Post-Traumatic Stress Disorder Symptoms in Phase 3 Study. Pharmacy Times. September 15, 2023. Accessed May 8, 2024. https://www.pharmacytimes.com/view/mdma-assisted-therapy-demonstrates-significant-reductions-in-post-traumatic-stress-disorder-symptoms-in-phase-3-study
  3. Hippensteele A. MAPS PBC Submits NDA to the FDA for MDMA-Assisted Therapy for PTSD. Pharmacy Times. December 12, 2023. Accessed May 8, 2024. https://www.pharmacytimes.com/view/maps-pbc-submits-nda-to-the-fda-for-mdma-assisted-therapy-for-ptsd
  4. Expert: MDMA Is Very Likely to Be FDA-Approved for PTSD by the End of 2023. Pharmacy Times. November 8, 2021. Accessed May 8, 2024. https://www.pharmacytimes.com/view/expert-mdma-is-very-likely-to-be-fda-approved-for-ptsd-by-the-end-of-2023
  5. Gallagher A. FDA Accepts New Drug Application for MDMA-Assisted Therapy for PTSD. Pharmacy Times. February 13, 2024. Accessed May 8, 2024. https://www.pharmacytimes.com/view/fda-accepts-new-drug-application-for-mdma-assisted-therapy-for-ptsd
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