On December 28, 2023, the FDA Informed MAPS that the Partial Clinical Hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) would be continued. This Clinical Hold letter rejects the study of smoked marijuana and vaporized marijuana and does not directly address any of the substantive responses in the Complete Response to FDA’s Clinical Hold submitted by MAPS on November 30, 2023.
Despite the increasingly widespread use and acceptance of cannabis in patients with PTSD, there is a lack of safety data on cannabis that models real-world consumption. Most cannabis studies to date do not reflect the average daily dose and percent composition of THC cannabis consumed by medical cannabis users. Yet the Clinical Hold letter does not indicate that the FDA will consider scientific evidence to support the use of either smoking or vaporization in future cannabis clinical research.
Proposed Study MJP2 study 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 route 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 legalization and cultivation of cannabis continues to evolve. MAPS remains committed to addressing this public health priority through rigorous scientific research.
As a result of this continued Clinical Hold, MAPS plans to submit a Formal Dispute Resolution Request (FDRR) to appeal this decision.