The U.S. Food and Drug Administration (FDA) and the Reagan-Udall Foundation recently held a hybrid public meeting to address the critical need for advancing innovative therapies for Post-Traumatic Stress Disorder (PTSD). The meeting brought together federal agencies, experts, and individuals with PTSD to discuss the current treatment landscape and potential new approaches, with a significant focus on psychedelic-assisted therapies, particularly MDMA-assisted therapy.
Current PTSD Treatment Landscape and Unmet Needs
During the meeting, Bernard A. Fischer, MD, Deputy Director of the Division of Psychiatry in the FDA's Office of New Drugs, noted that PTSD was not recognized as a mental health disorder until the 1980s. He acknowledged the limitations of current treatments, such as sertraline and paroxetine, which provide only symptomatic relief and are not effective for all patients. Fischer emphasized the FDA's recognition of the unmet need for safe and effective PTSD treatments and advised clinical trials to have representative samples.
Support for MDMA-Assisted Therapy
Despite the FDA's recent rejection of Lykos Therapeutics' application for MDMA-assisted therapy, the treatment received substantial support during the stakeholder comment segment of the meeting. Robert M. Grant, MD, MPH, professor of Medicine at the University of California-San Francisco, criticized the FDA's review process, stating that the agency failed to provide consistent guidance and essential context to its advisors.
Mary Armstrong, an individual with PTSD, shared her personal experience with MDMA-assisted therapy, stating that it allowed her to reframe a lifetime of trauma after other treatments had failed. "This can make all of the difference in whether someone lives or does not," Armstrong said.
Expert Perspectives on MDMA-Assisted Therapy
Experts at a MAPS press briefing following the FDA meeting highlighted the potential benefits of MDMA-assisted therapy. Dr. Dave Rabin, a board-certified psychiatrist and neuroscientist, stated that MDMA therapy is revolutionary because it enhances neuroplasticity, allowing the brain to rewire and learn new things. He added that MDMA fosters an environment where healing can happen quickly, something traditional psychotherapy struggles to achieve.
Dr. Bessel van der Kolk, a psychiatrist and pioneer in trauma research, explained that MDMA helps people revisit dark places and say, "This happened, but it wasn’t my fault." He emphasized that the most important finding is not how individuals relate to their trauma, but how they relate to themselves, and that psychedelic agents allow people to see their trauma with fresh eyes and move on with a new perspective.
Addressing Racial Trauma and Holistic Evaluation
Dr. Darron Smith, a physician associate and researcher, raised concerns about the DSM-5 diagnostic criteria, particularly when it comes to racial trauma. He argued for the need for more holistic tools to evaluate healing and transformation, especially for communities of color, as current metrics often exclude them.
Next Steps and Future Directions
MAPS is intensifying efforts to educate healthcare providers and policymakers about the potential benefits of psychedelic-assisted therapies and is working with regulatory bodies to ensure their safe and effective implementation. Betty Aldworth, MAPS Director of Communications & Post-Prohibition Strategy, noted that states like Colorado and Oregon have already implemented regulated psychedelic treatment models, and MAPS is committed to working with communities across the U.S. and globally to advance safe, legal access to these treatments.
