FDA Rejects PTSD Therapy, Drawing Criticism From Veterans

An advisory panel for the Federal Drug Administration (FDA) has rejected the authorization of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). This decision has disappointed many, especially given the extensive research supporting the therapy’s potential benefits for mental health.

MDMA, known as ecstasy, remains a Schedule I narcotic despite promising results in treating PTSD. The rejection follows an application by the MAPS Public Benefit Corporation, filed in December, which sought FDA approval for MDMA’s use in PTSD treatment. MAPS CEO Amy Emerson highlighted the application as the culmination of over 30 years of research and collaboration aimed at bringing new treatment options to those suffering from PTSD, a condition with limited innovative solutions.

The FDA panel’s decision was based on perceived shortcomings in the presented research. “Advisers to the FDA examined the research’s flaws and overwhelmingly rejected MDMA as a valid treatment for PTSD,” NPR reported. Supporters of MDMA therapy were disappointed. Ingmar Gorman, involved in the scrutinized trials, expressed frustration: “It really doesn’t feel like the data was given its proper due.”

Emerson echoed this sentiment, acknowledging the unmet need for PTSD treatments and the difficulty of the panel’s task in evaluating a therapy combining drug and psychological interventions. Rep. Morgan Luttrell (R-TX), a retired Navy SEAL who has personally benefited from MDMA therapy, also voiced his disappointment. In an op-ed for Marijuana Moment, he stressed the positive impacts of psychedelics when used clinically and called for better education and understanding of their therapeutic benefits.

Juliana Mercer, a 16-year Marine Corps veteran and advocate for MDMA-assisted therapy, described the decision as a “big gut punch.” She highlighted the dashed hopes of veterans seeking effective treatment. Mercer attended the FDA panel hearing, noting the strong support from veteran organizations and individual veterans who testified about the therapy’s life-saving potential.

The U.S. Department of Veterans Affairs had found that 85 percent of participants in a study last year experienced significant benefits from MDMA therapy. Mercer emphasized the urgency of approval, pointing out the numerous calls from veterans inquiring about access to this promising treatment. The rejection of MDMA therapy by the FDA represents a significant setback for those advocating for innovative solutions to PTSD.