FDA Advisers Vote Against First MDMA Therapy to Treat PTSD

June 10, 2024

Written by Joao L. de Quevedo, MD, PhD


Joao L. de Quevedo, MD, PhD

The quest for innovative treatments for Post-Traumatic Stress Disorder (PTSD) faced a significant setback recently when an advisory panel to the U.S. Food and Drug Administration (FDA) voted against approving MDMA-assisted therapy. This decision, while disheartening to many advocates and patients, highlights the ongoing complexities and challenges in integrating psychedelic substances into mainstream medical practice.

A Brief Overview

MDMA, commonly known as ecstasy, has shown promise in treating PTSD in several clinical trials. Proponents argue that MDMA-assisted psychotherapy can provide substantial relief for patients who have not responded to traditional treatments. The Multidisciplinary Association for Psychedelic Studies (MAPS) has been at the forefront of this research, demonstrating that MDMA, when used in a controlled, therapeutic setting, can reduce PTSD symptoms significantly.

The Advisory Panel’s Decision

Despite these promising results, the FDA advisory panel’s vote against MDMA therapy underscores several vital concerns. Primarily, the panel cited the need for more extensive research to fully understand the long-term effects and safety of MDMA use in therapeutic settings. Issues such as the potential for misuse, the psychological impacts of MDMA outside controlled environments, and the need for standardized treatment protocols were central to the panel’s reservations.

Implications for Patients

For the millions of people with PTSD, this decision represents a significant delay in accessing potentially life-changing treatment. Traditional therapies, including cognitive-behavioral therapy and pharmacological interventions like SSRIs, do not work for everyone. MDMA therapy offered hope for those who felt left behind by existing treatment options. The delay means continued reliance on treatments that may be less effective or carry significant side effects.

The Path Forward

While the advisory panel’s decision is a setback, it does not mark the end of MDMA-assisted therapy. The vote emphasizes the need for more rigorous and comprehensive studies to address the concerns raised. MAPS and other organizations will likely continue their research, striving to provide the additional data required to meet the FDA’s stringent standards.

Furthermore, this decision highlights the broader challenge of integrating psychedelic therapies into conventional medicine. The stigma associated with psychedelics, regulatory hurdles, and the need for specialized training for therapists all contribute to a slow and cautious approach by regulatory bodies.


The FDA advisory panel’s vote against MDMA therapy for PTSD is a poignant reminder of the challenges faced in pioneering new treatments. While disappointing, it also serves as a call to action for continued research and advocacy. As our understanding of MDMA and other psychedelics grows, so too does the potential for innovative therapies that could transform the lives of those who have PTSD. The journey toward acceptance and approval of psychedelic-assisted therapies may be long, but the potential benefits make it a path worth pursuing.


MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.

Mitchell JM, Ot’alora G M, van der Kolk B, Shannon S, Bogenschutz M, Gelfand Y, Paleos C, Nicholas CR, Quevedo S, Balliett B, Hamilton S, Mithoefer M, Kleiman S, Parker-Guilbert K, Tzarfaty K, Harrison C, de Boer A, Doblin R, Yazar-Klosinski B; MAPP2 Study Collaborator Group.Nat Med. 2023 Oct;29(10):2473-2480. doi: 10.1038/s41591-023-02565-4. Epub 2023 Sep 14. PMID: 37709999



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