FDA Grants Breakthrough Therapy Designation to MDMA (Ecstasy) for PTSD

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA (the main compound found in ecstasy) for the treatment of posttraumatic stress disorder (PTSD).

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic 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.

Read moreFDA Grants Breakthrough Therapy Designation to MDMA (Ecstasy) for PTSD