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.

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F.D.A. Approves New Phase 3 Studies for Ecstasy as PTSD Treatment

EcstasyThe Food and Drug Administration has given approval to Phase 3 clinical trials of MDMA (ecstasy) for the treatment of post traumatic stress disorder (PTSD). This is the final step before the potential approval of ecstasy as a prescription drug.

The move comes after several successful Phase 2 studies of ecstasy, which included 130 PTSD patients. These were conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS). The new research will include at least 230 participants and will also be conducted by MAPS.

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