The FDA recently granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD, according to a release from the Multidisciplinary Association for Psychedelic Studies.
Additionally, the FDA and the Multidisciplinary Association for Psychedelic Studies (MAPS) reached an agreement for the design of two phase 3 trials on MDMA-assisted psychotherapy for severe PTSD.
“Reaching agreement with FDA on the design of our phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Amy Emerson, BS, executive director of the MAPS Public Benefit Corporation, said in a press release. “Our phase 2 data [were] extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete phase 3.”
Phase 3 trials will assess efficacy and safety of MDMA-assisted psychotherapy among 200 to 300 individuals with PTSD aged 18 years and older. Trials will be conducted in the United States Canada, and Israel.
Study participants will be randomly assigned to receive three day-long sessions of MDMA or placebo plus psychotherapy over 12 weeks. Participants will also receive twelve 90-minute, nondrug preparatory and integration sessions.
Clinician Administered PTSD Scale scores will be the primary study endpoint.
Enrollment for the first phase 3 trial, MAPP1, will begin in spring 2018 after completion of an open-label, lead-in training study.
Efficacy of MDMA-assisted psychotherapy was shown in phase 2 trials conducted among 107 individuals with chronic, treatment-resistant PTSD and a mean illness duration of 17.8 years.
Results indicated 61% of 107 individuals did not meet criteria for PTSD after three sessions of MDMA-assisted psychotherapy 2 months after treatment.
At 12-month follow-up, 68% of participants did not met PTSD criteria.
MDMA transiently increased heart rate, blood pressure and body temperature in a dose-dependent manner generally not problematic for healthy individuals, according to the release.
Serious adverse events were uncommon and non-life threatening.
“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,” Rick Doblin, PhD, founder and executive director of MAPS, said in the release. “Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency.”