On October 10, 2024, MAPS submitted a Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). This response addressed the four key clinical hold issues identified in the prior FDA Clinical Hold letter received in December 2023. This Complete Response also incorporates the FDA’s additional guidance and updated conclusions expressed in the Formal Dispute Resolution Request (FDRR) Appeal Denied Letter received on September 19, 2024.
After over two years of correspondence since the original submission of Study MJP2, the FDA Division of Psychiatry Products (DPP) issued a fifth Clinical Hold Letter in December 2023 reiterating previously raised concerns regarding the safety of the proposed dose of THC (which was designed to mirror the real-world use of cannabis), the safety of the administration methods of both smoking and vaporization, and the inclusion of cannabis naive participants.
Given the stalled progress on resolving the clinical hold with the Division, MAPS submitted an FDRR to appeal the decision to the DPP’s overseeing Office of Neuroscience. The FDRR reviewed the regulatory history and the previously presented safety data on cannabis and vaporization devices with respect to the proposed study population and treatment conditions.
On September 19, 2024, MAPS received an Appeal Denied Letter from the Office of Neuroscience in response to the FDRR. Although the Office of Neuroscience denied the appeal, indicating that the study would remain on clinical hold, MAPS successfully achieved agreement on three key issues. In this communication, FDA revised its position to now conclude that the proposed dose of THC and proposed administration methods of smoking or vaporizing cannabis flower do not present an unreasonable risk to the PTSD patient population, provided that the risks of smoking and/or vaporizing high-potency THC are appropriately disclosed to participants in the informed consent process. However, the Office of Neuroscience agreed with the DPP that it is unacceptable to enroll cannabis naive participants who do not have prior experience inhaling smoked or vaporized cannabis.
The Appeal Denied letter indicated that the FDA will allow cannabis research that models real-world consumption provided that the risks of study participation do not outweigh the possible benefits of treatment and that the risks are adequately explained to the study participants.
Following receipt of the FDRR response, MAPS submitted a sixth Complete Response to the Clinical Hold on October 10, 2024. This response included a revised protocol and informed consent form that incorporates the FDA’s advice and concerns. Given the updated conclusions the Division reached through the FDRR process and the clarity of the FDA’s remaining concerns, MAPS is confident that the sixth Complete Response will be sufficient to remove the extended clinical hold.