FDA Public Meeting Reveals Federal Support For Psychedelics In PTSD Care
Federal agencies recently convened in a pivotal public meeting, hosted by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), to discuss emerging treatments for post-traumatic stress disorder (PTSD), with a focus on the potential of psychedelics. As Lexology reported, the September 6 event, attended by representatives from the FDA, Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Defense (DoD) and Department of Veterans Affairs (VA), focused on the urgent need for innovative PTSD therapies and evaluated the role psychedelics might play in future treatment protocols.
This gathering came shortly after the FDA’s decision to decline Lykos Therapeutics’ application for midomafetamine (MDMA)-assisted therapy for PTSD, a move that disappointed advocates who had seen the therapy as a breakthrough opportunity for PTSD sufferers. Despite this setback, the agencies highlighted ongoing efforts to address the limitations of current PTSD treatments and acknowledged a growing demand for effective, accessible solutions.
The FDA’s Position: ‘Unmet Need’ In PTSD Treatments
The FDA’s Bernard Fischer, deputy director of the division of psychiatry, highlighted critical gaps in current PTSD treatments, noting that approved drugs often don’t meet patient needs. He called for diverse studies to address various trauma experiences and the time from trauma to treatment.
Fischer acknowledged the unmet need for safe, effective PTSD treatments and emphasized the FDA’s Breakthrough Therapy designation, which offers guidance to developers of promising new treatments, including psychedelics. While the FDA’s refusal to approve MDMA-assisted therapy raised concerns, Fischer remained optimistic about future advancements if rigorous studies are conducted.
SAMHSA’s Investment In Trauma-Informed Care
Representing SAMHSA, …