On January 11, 2024, MAPS submitted to the FDA the 2023 Cannabis Data Safety Update Report (DSUR). The DSUR serves as the FDA Annual Report on the progress of the drug investigation over the last year. Very few updates were made to the DSUR this year, given that MJP2 has been on clinical hold since May 10, 2021 (see Study Timeline).
On November 30, 2023, MAPS submitted the fifth Complete Hold Response to the FDA. At the end of December 2023, MAPS received a Continued Clinical Hold letter from the FDA indicating that Study MJP2 would remain on clinical hold due to concerns about the safety of smoking and vaporizing cannabis, self-titrated dose, and the inclusion of cannabis naive users. In 2024, MAPS plans to submit a Formal Dispute Resolution Request to appeal the FDA’s decision to continue the clinical hold.
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.