FDA Submission of MDMA-Assisted Therapy Application Aims to Advance Mental Health Landscape

NEW YORK- In a landmark move, MAPS Public Benefit Corporation (MAPS PBC), a subsidiary of the notable Multidisciplinary Association for Psychedelic Studies (MAPS), has officially lodged a new drug application with the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy, potentially revolutionizing treatment for Post-Traumatic Stress Disorder (PTSD).

This submission, the culmination of over three decades of meticulous clinical research, is a watershed moment for mental health treatment. MDMA, colloquially known as Ecstasy, could shift the paradigm of PTSD therapy. The FDA’s 2017 Breakthrough Therapy designation for MDMA-assisted psychotherapy had already set the stage, indicating its significant potential over existing treatment methods.

MAPS PBC’s determined pursuit of this initiative follows promising results from two pivotal clinical trials. These trials explored MDMA-assisted therapy’s effectiveness in treating PTSD, leading to the decision announced in January to proceed with the new drug application (NDA) in the third quarter of 2023.

Amy Emerson, CEO of MAPS PBC, articulated the profound impact of this application, stressing its potential to offer a novel solution for adults living with PTSD. She underlined the lack of innovation in PTSD treatments over the past decades and expressed hope that MDMA-assisted therapy would spark further investment and research in mental health.

Decades of Research Underpin Application The NDA includes extensive data from studies like MAPP1 and MAPP2, both rigorous, randomized, double-blind, placebo-controlled Phase 3 studies. Their findings, published in Nature Medicine, underscored MDMA-assisted therapy’s efficacy and safety compared to placebo in participants with moderate to severe PTSD.

The MAPP2 study, enrolling 121 participants for a 12-week treatment, stood out for its inclusive participant demographics, reflecting the diverse population affected by PTSD in the United States. The significant improvement in PTSD symptoms among participants in the MDMA group, measured by established clinical scales, was a pivotal outcome of this research.

Emerson highlighted these Phase 3 results, emphasizing MDMA-assisted therapy’s potential as a breakthrough in treating individuals with PTSD, a population often left to endure prolonged suffering.

FDA’s Critical Review Ahead With MDMA’s breakthrough therapy status, MAPS PBC has requested a priority review of the NDA by the FDA. The agency has a 60-day window to decide on the application’s acceptance and the type of review it warrants. Approval by the FDA would necessitate a rescheduling of MDMA by the U.S. Drug Enforcement Administration, paving the way for its prescription-based medical use.

Industry leaders and advocates have weighed in on this development. Sherry Rais, CEO of Enthea, and Shawn Hauser, a partner at Vicente LLP, both expressed optimism and underscored the significance of this moment. It’s seen as a milestone not only for the healthcare and psychedelic industries but also for society at large, especially in light of America’s ongoing opioid crisis.

The potential FDA approval of MDMA for PTSD treatment, coupled with recent recommendations to reclassify cannabis, signifies a notable shift in federal drug policy, reflecting a broader acceptance of alternative therapeutic modalities.