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, chief medical officer Neeraj Gandotra outlined the agency's commitment to PTSD treatment through extensive funding and support for mental health services. Gandotra spotlighted SAMHSA's billion-dollar investment in crisis services and trauma-informed care, aimed at bolstering community mental health infrastructure.

SAMHSA's ReCAST program has been instrumental in training over 100,000 individuals in trauma-informed practices, with Gandotra highlighting that the National Child Traumatic Stress Network alone has reached over a million people.

Department Of Defense: Pioneering A New Approach With M-PACT

Elyse Katz, a DoD contractor, introduced the Military and Veterans PTSD Adaptive Platform Clinical Trial (M-PACT), a groundbreaking study testing multiple drugs concurrently. This first-of-its-kind platform trial in psychiatric research shares placebo data across study arms for comprehensive treatment assessments. M-PACT includes four PTSD drugs, including a nasally administered ketamine formulation, and will gather data on clinical outcomes and biomarkers for a tailored treatment model. The trial invites industry stakeholders to propose drugs, reflecting the DoD's commitment to innovative PTSD care and advancing a precision medicine approach for individual patient needs.

VA's Commitment To Psychedelic Research

At the VA, efforts to explore psychedelics as viable PTSD treatments are gaining traction. Paula Schnurr, executive director of the VA National Center for PTSD, reiterated the agency's commitment to both researching and potentially implementing psychedelic therapies, particularly MDMA and psilocybin.

Miriam Smyth, acting director of the VA's Brain, Behavioral and Mental Health Broad Portfolio, shared that the VA has recently opened doors to researchers seeking funds for psychedelic studies, marking a shift from past practices where funding relied on external sources. The VA's Million Veteran Program MIND initiative, currently underway, further reflects this new approach by conducting surveys across VA facilities to assess neuropsychiatric disorders.

Also Read: Veterans Affairs Eyes Funding For New MDMA-PTSD Trial After FDA Setback

Public Comments Highlight PTSD Treatment Gaps

During the public comment session, veterans and advocates emphasized the life-altering impact of PTSD and the limitations of current treatments. Many shared personal stories of therapeutic success with MDMA-assisted therapy, underscoring the need for effective solutions to counter the significant suicide risk associated with untreated PTSD. For some veterans, MDMA therapy provided relief not found with traditional treatments, illustrating the potential for psychedelics to fill existing treatment gaps.

MAPS Pushes For Expanded Psychedelic Access

After the FDA meeting, the Multidisciplinary Association for Psychedelic Studies (MAPS) submitted comments advocating for psychedelic therapies in PTSD treatment. MAPS argued that combining MDMA with therapy offers a more ethical and potentially effective approach than using MDMA alone. They noted that the placebo group in Lykos’ trials might show that therapy alone could yield better outcomes than current treatments. "MDMA-assisted therapy placebo group in the Lykos trials would likely demonstrate that the inner-directed therapy alone generates better responses than current front-line treatments," noted MAPS, highlighting the potential role of therapy in maximizing patient outcomes.

To speed up psychedelic research and approval, MAPS proposed strategies such as simplified access to psychedelics in Phase 3 trials, leveraging Right to Try legislation, and creating an evidence accelerator similar to those used during the COVID-19 pandemic.

Future Prospects For PTSD Treatment

As federal agencies continue exploring new avenues for PTSD treatment, stakeholders in psychedelic research may find new opportunities to contribute to mental health advancements. From seeking expanded funding to participating in clinical trials and therapist training programs, the public meeting underscored a collective commitment to addressing PTSD through innovative approaches. Despite regulatory hurdles, this collaborative effort signals a potential shift in PTSD care, with psychedelics poised to play a growing role in future treatment options.

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