NDA Submitted for MDMA-Assisted Therapy for Posttraumatic Stress Disorder

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MAPS Public Benefit Corporation has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for midomafetamine capsules (MDMA) used in combination with psychotherapy for individuals with posttraumatic stress disorder (PTSD). If approved, this would be the first official psychedelic-assisted therapy.^1,2

“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,” said Amy Emerson, chief executive officer of MAPS. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”

The NDA submission included results from the 2 randomized, double-blind, placebo-controlled phase 3 studies, MAPP1 and MAPP2, which evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) versus placebo with therapy in patients with moderate or moderate and severe PTSD.

MAPP1 examined the safety and efficacy of MDMA-AT versus placebo control in treating individuals with severe PTSD. The results showed that 88% of the participants treated with MDMA-AT had a clinically significant improvement in their PTSD symptoms and 67% no longer qualified for a PTSD diagnosis. Common adverse events included muscle tightness, decreased appetite, nausea, sweating, pupil dilation, and feeling cold. No serious adverse events were reported.³

MDMA-AT received Breakthrough Therapy designation in 2017. As such, MAPS has requested the FDA grant priority review of the NDA. If approved by the FDA, the US Drug Enforcement Agency would need to reschedule MDMA in order to make it available for prescription medical use.

References

1. MAPS PBC announces submission of new drug application to the FDA for MDMA-assisted therapy for PTSD. News release. Cision. December 12, 2023. https://www.prnewswire.com/news-releases/maps-pbc-announces-submission-of-new-drug-application-to-the-fda-for-mdma-assisted-therapy-for-ptsd-302011980.html

2. Breaking: MAPS PBC files new drug application for MDMA-assisted therapy for PTSD. News release. Psychedelic Alpha. December 12, 2023. https://psychedelicalpha.com/news/breaking-maps-pbc-files-new-drug-application-for-mdma-assisted-therapy-for-ptsd

3. Kuntz L. MDMA-assisted therapy for PTSD: completion of phase 3 study. Psychiatric Times. November 18, 2022. https://www.psychiatrictimes.com/view/mdma-assisted-therapy-for-ptsd-completion-of-phase-3-study