FDA: Breakthrough Therapy Designation Granted for MDMA-Assisted PTSD Pyschotherapy
MAPS previously completed proof-of-concept Phase 2 studies which demonstrated efficacy in PTSD patients.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to 3,4-methylenedioxymethamphetamine (MDMA) for the treatment of posttraumatic stress disorder (PTSD). The decision marks the first time that a psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials.
The clinical program for MDMA is being sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). The organization is planning 2 clinical trials (MAPP1 and MAPP2) after coming to an agreement with the FDA through the Special Protocol Assessment Process (SPA), which contains guidance from the FDA on all aspects of the trial so that they are acceptable to support clinical approval. As MDMA is a schedule I drug the SPA agreement is required before any trial is initiated.
The first trial (MAPP1) will begin enrolling patients in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall. MAPS previously completed proof-of-concept Phase 2 studies which demonstrated efficacy in PTSD patients. After 3 sessions of MDMA-assisted psychotherapy, 68% of patients no longer suffered from PTSD at the 12-month follow-up.
“Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly,” said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation.
The trials will enroll between 200 and 300 participants with PTSD aged ≥18 in the US, Canada and Israel. The participants will be randomized to receive either 3 day-long sessions of MDMA or placebo in combination with a 12-week period of psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5).
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Founder and Executive Director of MAPS
As of now MAPS has raised approximately $12.5 million for the Phase 3 trials, which is half of what is need to bring the trials to completion.
FDA grants breakthrough therapy designation for MDMA-assisted psychotherapy for PTSD, agrees on special protocol assessment for phase 3 trials [press release]. Santa Cruz, CA: MAPS. http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials. Published August 26, 2017. Accessed September 6, 2017.