MAPS PBC Submits New Drug Application for MDMA-Assisted Therapy for PTSD

MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it has submitted a new drug application to the US Food and Drug Administration (FDA) for the use of MDMA in combination with psychological intervention (which includes psychotherapy) or talk therapy, along with other support services, to treat post-traumatic stress disorder (PTSD).

The filing is the first new drug application (NDA) to the FDA for any psychedelic-assisted therapy.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” MAPS PBC CEO Amy Emerson said in a news release.

Emerson added that MAPS PBC hopes that MDMA-assisted therapy for PTSD gaining FDA approval would serve as a catalyst for “additional investment into new research in mental health.”

MAPS PBC’s submission included results from 2 randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) that evaluated the safety and efficacy of MDMA-assisted therapy compared to treatment that used a placebo with therapy. The studies involved patients diagnosed with moderate or moderate-to-severe PTSD. Both studies met their primary and secondary endpoints, and no serious adverse events were reported in the MDMA group of either study. Findings from the 2 studies were published in the journal Nature Medicine.

With the FDA granting MDMA Breakthrough Therapy designation in 2017, MAPS PBC has requested that the administration grant Priority Review of its NDA. The FDA will have 60 days to determine whether the application will be accepted for review and whether it will receive priority or standard review, processes which are 6 months or 10 months, respectively. If the NDA is approved, the US Drug Enforcement Agency (DEA) would be required to reschedule MDMA to make it available for prescription medical use.

References

MAPS PBC announces submission of new drug application to the FDA for MDMA-assisted therapy for PTSD. News release. MAPS Public Benefit Corporation. December 12, 2023. Accessed December 12, 2023.

Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: A randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021;27(6):1025-1033. doi:10.1038/s41591-021-01336-3

Mitchell JM, Ot’alora GM, van der Kolk B, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023;29, 2473–2480. doi.org/10.1038/s41591-023-02565-4