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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DEA Approves Study of Ecstasy for Anxiety Associated with Life-Threatening Illness

Ecstasy tablets.
Ecstasy tablets.

The Drug Enforcement Adminsitration (DEA) has approved a study of MDMA (pure ecstasy) for the treatment of anxiety associated with terminal illnesses.

“On March 13, 2015, the U.S. Drug Enforcement Administration approved the Schedule I license for Phil Wolfson, M.D., the Principal Investigator for our upcoming study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness”, the Multidisciplinary Association for Psychedelic Studies (MAPS) said in a recent newsletter. “This was the final regulatory approval needed for the study, which was approved by an Institutional Review Board (IRB) on September 16, 2014, the Research Advisory Panel of California (RAPC) on December 15, 2014, and by the U.S. Food and Drug Administration on November 13, 2014.”

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