On August 23, 2024, MAPS submitted a Formal Dispute Resolution Request to appeal the Clinical Hold placed on the Phase 2 study of cannabis for Veterans with PTSD (MJP2) by the FDA Division of Psychiatry Products (DPP). The FDRR was submitted in response to an FDA Clinical Hold letter received in December 2023, which rejected the study of smoked marijuana and vaporized marijuana.
MAPS initially submitted the clinical study protocol for MJP2 on March 9, 2021. Over the 2 years that followed, DPP issued, and MAPS responded to, four Partial Clinical Hold Clinical Hold letters which raised a variety of issues primarily centered on DPP’s concerns about potential risks associated with the proposed dosing and administration of cannabis flower (see Study Timeline).
MAPS conducted a Type A meeting with the FDA in June 2023 in an effort to reach alignment on the hold issues. Despite the constructive nature of this meeting and MAPS effort to incorporate the FDA’s advice from both the Type A meeting and post-meeting comments from the FDA Division of Pulmonology, Allergy, and Critical Care (DPACC) into its Complete Response submitted in November 2023, DPP issued a fifth Clinical Hold letter on December 28, 2023.
The Clinical Hold Letter reiterated the previously raised concerns regarding the safety of the proposed dose of THC (which was designed to mirror the real-world use of cannabis), the administration methods of both smoking and vaporization as “not safe delivery methods,” and the inclusion of cannabis naive participants. The letter did not directly address any of the substantive responses or the thorough review of the relevant safety literature presented by MAPS in the November 2023 Complete Response.
MAPS therefore submitted a Formal Dispute Resolution Request (FDRR) which serves an appeal to the DPP’s overseeing Office of Neuroscience to request a thorough review of the data submitted to the FDA. The FDRR reviews the regulatory history and the previously presented safety data on cannabis and vaporization devices with respect to the proposed study population and treatment conditions.
The FDRR argues that given the information presented to FDA to date, the proposed study MJP2 does not present “an unreasonable and significant risk of illness or injury” to proposed study participants living with posttraumatic stress disorder (PTSD). In consideration of the considerable lack of high-quality safety and efficacy data for cannabis, as noted in the FDA’s own 8-Factor Analysis for Cannabis, the FDRR reasserts that MJP2 may provide invaluable insights on the already widespread use of inhaled cannabis in individuals with PTSD.
The proposed Study MJP2 is intended to bolster the cannabis safety literature and contribute to a better understanding of the safety and effectiveness of real-world cannabis consumption by modeling commonly used routes of administration, dose, and % THC content. Clinical research on the safety, as well as potential risks and benefits, of typical consumption patterns of cannabis is a public health priority as the legal and regulatory landscape of cannabis continues to evolve. MAPS remains committed to addressing this public health priority through rigorous scientific research and working to remove regulatory barriers to the conduct of such research.