The FDA has accepted a New Drug Application (NDA) from Lykos Therapeutics (formerly MAPS Public Benefit Corporation) for midomafetamine (MDMA) to treat post-traumatic stress disorder (PTSD), the corporation announced in a press release.1 The NDA also received Priority Review and was assigned a Prescription Drug User Fee Act (PDUFA) date of August 11, 2024.
The NDA submission was supported by results from 2 phase 3 trials: MAPP1 (NCT03537014) and MAPP2 (NCT04077437). The randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of MDMA used in combination with psychological intervention—including psychotherapy and other supportive services—versus placebo in patients diagnosed with severe or moderate to severe PTSD.
Key Takeaways
- The FDA has accepted and granted priority review to a New Drug Application from Lykos Therapeutics for MDMA to treat PTSD. The NDA was assigned a PDUFA date of August 11, 2024.
- The NDA submission was supported by results from the MAPP1 and MAPP2 phase 3 clinical trials evaluating the efficacy and safety of MDMA used in combination with psychological intervention versus placebo. Both studies were published in Nature Medicine and met their primary and secondary endpoints.
- If approved by the FDA Lykos’ would be the first MDMA-assisted therapy and psychedelic-assisted therapy.
MAPP1 included 90 participants randomly assigned to receive manualized therapy with MDMA or placebo, combined with 3 preparatory and 9 integrative therapy sessions. The study found that MDMA induced significant and robust attenuation in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).2 MAPP2 included 104 participants who were randomly assigned to MDMA-assisted therapy or placebo with therapy. The study found that mean changes in CAPS-5 score was -23.7 for MDMA, compared to -14.8 for placebo.3
Both studies, which were published in Nature Medicine, met their primary and secondary endpoints.
"Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD," Amy Emerson, chief executive officer of Lykos, said in a release.1 "We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved."
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MDMA (3,4-Methylenedioxy-methamphetamine), more commonly known as ecstasy, is an entactogen—a type of psychoactive compound that’s characterized by its ability to increase self-awareness. It is classified by the Drug Enforcement Agency as a Schedule I drug under the Controlled Substances Act.
MDMA was previously granted Breakthrough Therapy designation in 2017 by the FDA for the treatment of PTSD. If approved by the federal agency, Lykos’ would be the first MDMA-assisted therapy and psychedelic-assisted therapy.
“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,” Rick Doblin, founder and president at the Multidisciplinary Association for Psychedelic Studies (MAPS), said in a release.4 “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.”
READ MORE: Mental and Behavioral Health Resource Center
References
2. Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025–1033 (2021). https://doi.org/10.1038/s41591-021-01336-3
3. Mitchell, J.M., Ot’alora G., M., van der Kolk, B. et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med 29, 2473–2480 (2023). https://doi.org/10.1038/s41591-023-02565-4
