Posted by Michael Wonder on 30 Aug 2017
FDA grants breakthrough therapy designation for MDMA-assisted psychotherapy for PTSD, agrees on special protocol assessment for phase 3 trials
26 August 2017 - Breakthrough therapy designation ensures that FDA will work closely with MAPS to complete Phase 3 trials as efficiently as possible.
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. FDA has granted breakthrough therapy designation to MDMA for the treatment of post-traumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct.
