FDA Approval of MDMA Assisted Psychotherapy for PTSD ✔️💊
The FDA has approved Breakthrough Therapy Designation including design, primary endpoint, and statistical approach for phase 3 of MAPS (Multidisciplinary Association for Psychedelic Studies) MDMA-assisted psychotherapy for patients with severe PTSD starting in 2018. MAPS, a 501(c)(3) nonprofit organization has raised ½ of the $25 million needed to conduct these trials. The first of these trials are scheduled for enrollment in Spring of 2018. Dr. Rick Doblin, PhD, founder and executive director of MAPS said
"For the first time ever, psychedelic-assisted psychotherapy will be evaluated in phase 3 trials for possible prescription use," "Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency,"
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