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# First Psychedelic NDA Filing Claimed for PTSD Therapy
- URL: https://www.fdaweb.com/first-psychedelic-nda-filing-claimed-for-ptsd-therapy/
- Published: 2023-12-12T12:00:00.000Z
- Updated: 2026-09-14T14:18:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155972

MAPS Public Benefit Corp. has filed what it calls the first NDA submission for a psychedelic-assisted therapy*,* MDMA (midomafetamine capsules), for use in combination with psychological intervention for treating post-traumatic stress disorder (PTSD). Psychological intervention includes psychotherapy, talk therapy, or other supportive services provided by a qualified healthcare provider, [according to the company](https://mapsbcorp.com/news/mdma-for-ptsd-fda-submission/?ref=fdaweb.com).

The submission included results from “numerous” studies including two Phase 3 studies evaluating the efficacy and safety of the MDMA-assisted therapy versus placebo in participants diagnosed with moderate or moderate and severe PTSD, respectively. The [MAPP1](https://www.nature.com/articles/s41591-021-01336-3?ref=fdaweb.com) and [MAPP2](https://www.nature.com/articles/s41591-023-02565-4?ref=fdaweb.com) studies met their primary and secondary endpoints and were published in *Nature Medicine*, the company says.

The primary endpoint was a measurement of change from baseline in clinician-administered PTSD Scale for DSM-5 and the key secondary endpoint was improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale, according to the company. “No serious adverse events were reported in the MDMA group in both studies,” it says.

MAPS says FDA had previously granted MDMA a breakthrough therapy designation, and it is now requesting a priority review for the submission, expecting an agency decision within 60 days.

MDMA is an entactogen, a class of psychoactive drugs that “produce experiences of emotional communion, oneness, relatedness, emotional openness and is thought to have use for various medical conditions,” MAPS says. Outside of the clinic, MDMA is known as the party drug ecstasy.