MAPS Public Benefit Corporation (PBC) announced the final participant’s last Evaluation and Exit Planning therapeutic session was completed in MAPP2, a multi-site Phase 3 study of MDMA-assisted therapy for the treatment of Post-Traumatic Stress Disorder (PTSD.)

A wholly-owned subsidiary of the renowned Multidisciplinary Association for Psychedelic Studies, MAPS PBC was founded in 2014 as a non-profit organization with the goal of developing and commercializing prescription psychedelics following a public benefit focus.

The clinical trials program for MDMA-assisted therapy (MDMA-AT) for PTSD has been sponsored by MAPS since 2000 and administered by MAPS PBC since 2014. 

Following the FDA’s designation of the treatment as a ”breakthrough therapy” in 2017, MAPS applied for and received Special Protocol Assessment (SPA) for further guidance on trial size and design. 

The SPA commits the FDA to approve the treatment provided two Phase 3 studies obtain statistical significance, with no identified new safety issues and proper gathering of data.

The results of the first Phase 3 trial were statistically significant, with a …

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