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# Group Pushes MDMA-Assisted Therapy for PTSD
- URL: https://www.fdaweb.com/group-pushes-mdma-assisted-therapy-for-ptsd/
- Published: 2025-08-14T12:00:00.000Z
- Updated: 2026-09-14T15:19:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159685

In an 8/14 open letter to HHS secretary **Robert F. Kennedy**, Jr. and FDA commissioner **Martin Makary**, the Multidisciplinary Association for Psychedelic Studies (MAPS) is calling for approval for MDMA-assisted therapy for those living with treatment-resistant trauma. The [letter](https://maps.org/2025/08/14/open-letter-hhs-fda/?ref=fdaweb.com) notes that one year ago, FDA issued a complete response letter (CRL) NDA seeking approval for MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD).

“Despite successful Phase 3 clinical trials and broad bipartisan support, MDMA-assisted therapy for PTSD remains inaccessible to those who need it most,” MAPS says.

The NDA was [submitted](https://www.fdaweb.com/first-psychedelic-nda-filing-claimed-for-ptsd-therapy/) in 12/2023 by the MAPS Public Benefit Corp. At that time, MAPS said the submission included results from numerous studies, including two Phase 3 studies evaluating the safety and efficacy of MDMA-assisted therapy versus placebo in participants diagnosed with moderate or moderate and severe PTSD, respectively. The company said the studies met their primary and secondary endpoints.

MDMA (midomafetamine) is an entactogen, a class of psychoactive drugs that “produce experiences of emotional communion, oneness, relatedness, emotional openness,” MAPS said. Outside the clinical setting, MDMA is known as the party drug ecstasy.

Although the CRL was not publicly released, media sources indicate that FDA’s concerns involved insufficient evidence of safety and effectiveness, functional unblinding bias, study design and expectancy bias, limited data on the durability of treatment effects, safety, and trial ethical and conduct issues.

The MAPS letter says the company remains hopeful that its modality will receive FDA approval soon and is encouraged by recent statements from Kennedy indicating he understands the need to make the approval a priority.

“Last year’s decision cost lives by delaying access to a treatment that may be a lifeline for the millions of Americans suffering from trauma disorders that conventional treatments often fail to treat, despite statistical significance and demonstrated efficacy found in clinical trials designed in collaboration with world-class experts from the Veterans Administration and renowned academic institutions including New York University, Harvard, and University of California San Francisco,” MAPS writes.