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Federal Agencies Highlight Efforts to Advance PTSD Treatments, Including Psychedelics

• Federal agencies convened to discuss strategies for advancing PTSD treatments, including exploring the potential of psychedelics, in response to the urgent need for more effective mental health interventions. • The FDA emphasized the need for diverse study populations in PTSD drug development, considering various traumatic events and timelines, and highlighted the Breakthrough Therapy designation for promising treatments. • The DoD's M-PACT trial, a platform-type study, is evaluating multiple drugs, including intranasal ketamine, using a precision medicine approach to tailor treatments based on individual patient characteristics. • The VA is expanding its support for psychedelic research, allowing researchers to submit funding proposals for studies involving MDMA and psilocybin, and is rolling out a mental health survey (MVP MIND) across facilities.

Following the FDA's decision to decline approval of MDMA-assisted therapy (MDMA-AT) for PTSD, federal agencies are reaffirming their commitment to exploring alternative treatments, including psychedelics. A recent public meeting organized by the Reagan-Udall Foundation for the FDA highlighted ongoing efforts and initiatives to advance PTSD research and treatment.

Federal Agency Initiatives

Representatives from the FDA, SAMHSA, DoD, and VA discussed their respective approaches to addressing the unmet need for effective PTSD treatments.
FDA's Perspective
Bernard Fischer from the FDA acknowledged the limitations of existing FDA-approved drugs for PTSD and emphasized the agency's commitment to safe and effective alternatives. He advised drug developers to ensure studies include diverse demographic representation, encompassing various traumatic events and timelines. Fischer also highlighted the Breakthrough Therapy designation program, which facilitates communication and guidance for drugs with potential advantages over existing therapies.
SAMHSA's Focus
Neeraj Gandotra of SAMHSA outlined the agency's focus on service grants and technical assistance, including mental health block grants and community behavioral health clinics. SAMHSA's ReCAST program has trained over 100,000 mental health professionals in trauma-informed care, while the National Child Traumatic Stress Network has assisted over a million individuals.
DoD's Adaptive Platform Trial
Elyse Katz from the DoD discussed the Military and Veterans PTSD Adaptive Platform Clinical Trial (M-PACT), the first platform-type trial in psychiatry. This trial allows for simultaneous and sequential testing of multiple drugs, including intranasal racemic ketamine, with shared placebo data across treatment arms. The trial incorporates biomarker and clinical assessment data to adopt a precision medicine approach.
VA's Commitment to Psychedelic Research
Paula Schnurr and Miriam Smyth from the VA emphasized the agency's commitment to supporting and conducting psychedelic research, including evaluations of MDMA and psilocybin for PTSD and depression. VA researchers can now submit funding proposals for psychedelic research through the VA's intramural research program. The VA is also rolling out the Million Veterans Program Measures Investigating Neuropsychiatric Disorders (MVP MIND) mental health survey.

Stakeholder Perspectives and MAPS Commentary

During the public comment period, many speakers shared personal experiences with MDMA-assisted therapy, highlighting its potential benefits for treating PTSD. Rick Doblin and Betty Aldworth from MAPS submitted comments emphasizing the potential of psychedelic-assisted therapies and suggesting strategies to increase research and FDA approval, including simplifying Expanded Access programs, allowing access to controlled substances under investigation through Right to Try legislation, creating an expert panel to evaluate drug-therapy combinations, and establishing an evidence accelerator.

Implications for Psychedelic Stakeholders

The Reagan-Udall Foundation public meeting underscores the federal government's recognition of the need for safe and effective PTSD treatments and its willingness to explore innovative approaches, including psychedelics. Stakeholders can leverage these programs by submitting psychedelics for research, accessing funding, participating as trial sites, enrolling patients, and engaging in therapist training and patient-access advocacy.
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Reference News

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Insights for Psychedelic Stakeholders From Recent FDA Public Meeting on Advancing ... - Lexology
lexology.com · Oct 30, 2024

On September 6, 2024, the Reagan-Udall Foundation for the FDA held a public meeting on advancing PTSD treatments, includ...

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