The non-profit Multidisciplinary Association for Psychedelics Studies (MAPS) and its subsidiary MAPS Public Benefit Corporation finished the enrollment stage for the second Phase 3 clinical trial on MDMA (MAPP2).
A year later after publishing the results from its first Phase 3 trial (MAPP1), MAPS announced that MAPP2 is expected to reach completion by October 2022, enabling the organization to then file a New Drug Application with the FDA in the first half of 2023.
If the FDA were to grant the New Drug status, commercialization of the substance would mean a more than interesting opportunity for companies such as Field Trip (NASDAQ: FTRP), Atai (NASDAQ: ATAI) and MindMed (NASDAQ: MNMD).
MAPP2 will develop in 13 different sites in the United States and Israel with the goal of studying whether MDMA is a viable treatment for PTSD. The study will consist of three 90-minute preparatory sessions, three eight-hour MDMA-assisted therapy sessions and at least nine 90-minute integration sessions.
In a press release, MAPS noted that “among Americans exposed to trauma, people of color and LGBTQ+ individuals are more likely to develop PTSD, yet less likely to receive a diagnosis or have reasonable access to treatment.” For that reason, MAPS has established equity initiatives in therapist training and in participant recruitment.
Amy Emerson, CEO of MAPS PBC, said: “We are eagerly awaiting the possibility that our scientific inquiry may be confirmed in this critically important trial scheduled to be completed in October 2022.”
