Psychedelic-assisted MDMA psychotherapy will be evaluated in Phase 3 trials for PTSD.
The FDA announced that methylenedioxymethamphetamine, commonly known as MDMA, has been granted a Breakthrough Therapy Designation and has decided to move forward with the drug for treatment of post-traumatic stress disorder (PTSD).
A completed phase 2 trial, consisting of 107 patients who had suffered from chronic, treatment resistant PTSD for an average of 17.8 years, revealed that 61% of patients no longer qualified for PTSD after 3 sessions of MDMA-assisted psychotherapy. After 12-months, 68% no longer had PTSD.
The Multidisciplinary Association for Psychedelic Studies (MAPS) has been championing for research into MDMA, often the main ingredient in ecstasy, for 30 years. In a statement, the group said that the FDA “has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for 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, executive director of the MAPS Public Benefit Corporation (MPBC), said in a statement. "Our Phase 2 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 3."
The two organizations reached an agreement under the Special Protocol Assessment Process for 2 upcoming phase 3 trials (MAPP1 and MAPP2) on MDMA-assisted psychotherapy for severe PTSD patients.
The MAPP1 trial, “A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder,” will open enrollment in Spring 2018, upon the completion of an open-label lead-in training study.
"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, Founder and Executive Director of MAPS, said in a statement. "Now that we have agreement with FDA, we are ready to start negotiations with the European Medicines Agency."
The trials will examine the efficacy and safety in 200 to 300 participants over the age of 18 in the US, Israel, and Canada. MAPS announced that the subjects will be randomized to 3 day-long sessions with either placebo or MDMA paralleled with psychotherapy over a 12-week period. They will also receive “12 associated 90-minute non-drug preparatory and integration sessions.”
The phase 2 trial results are currently “being prepared for publication,” according to MAPS.