FDA Grants 'Breakthrough Therapy' Designation to MDMA for PTSD

Published Online: Monday, September 4th, 2017
The FDA has granted a "breakthrough therapy" designation to 3,4-methylenedioxymethamphetamine (MDMA), also known as the street-drug ecstasy, for the treatment of posttraumatic stress disorder (PTSD), and 2 phase 3 trials are in the works, according to a press release from the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS).1

MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of the 2 upcoming phase 3 trials, which 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.

The phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the US, Canada, and Israel. Participants will be randomly assigned to receive 3 day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

In MAPS' completed phase 2 trials with 107 participants, 61% no longer qualified for PTSD after 3 sessions of MDMA-assisted psychotherapy 2 months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.

FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials [news release]. Santa Cruz, Calif. MAPS website. Aug. 26, 2017. 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. Accessed Aug. 30, 2017. 

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