The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for 3,4-Methylenedioxymethamphetamine (MDMA) as a potential treatment (in combination with psychotherapy) for patients struggling with post traumatic stress disorder (PTSD).
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As announced by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), an agreement was also reached with the FDA for the design, primary endpoint and statistical approach for two Phase III trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
“Reaching agreement with FDA on the design of our Phase III programme and having the ability to work closely with the agency has been a major priority for our team,” said Amy Emerson, executive director of the MAPS Public Benefit Corporation (MPBC). “Our Phase II data was 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 III.”
“For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase III trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” added Rick Doblin, founder and executive director of MAPS. “Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency (EMA).”
The Phase III trials will assess the safety and efficacy of MDMA-assisted psychotherapy, with enrolment into the first trial to commence in Spring next year. Participants in the trial will be randomised to receive either MDMA or placebo in conjunction with psychotherapy. There will be three day-long sessions in total that will be given over a 12-week period. Additionally, each patient will be given 12 associated 90-minute non-drug preparatory and integration sessions.
The completed Phase II trial results are currently being prepared for publication.