On March 13, 2018, a shipment of pharmaceutical-grade MDMA, made under current Good Manufacturing Practices in a certified laboratory, arrived in the United States for use in MAPS-sponsored Phase 3 trials of treating posttraumatic stress disorder (PTSD) with MDMA-assisted psychotherapy.
MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 13 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for PTSD at planned Phase 3 sites across the United States and Canada. The purpose of this study is to provide the final training for our co-therapy teams.
These Study Initiation Visits provide training on study procedures to study sites where new co-therapy teams will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3. Each new co-therapy team will work with a single participant at their respective study site with supervision provided by MAPS’ therapy training team.
The study site in Fort Collins has conducted experimental treatment sessions with three participants, and the New Orleans study site has completed their second experimental treatment session. Study sites in Charleston, Los Angeles, San Francisco (two locations), Connecticut, New York (private practice), and Vancouver are screening participants.
The study site in Boulder, Colorado, received the necessary study drug on March 20. The study site in New York (private practice) will receive the study drug on March 28.
The Phase 3 trials starting in the summer of 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive 12 associated 90-minute non-drug preparatory and integration sessions along with three day-long sessions of either MDMA or placebo in conjunction with psychotherapy about a month apart. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
The trials builds on the promising results of MAPS’ completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD. MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting with an overnight stay.
On July 28, 2017, MAPS and the FDA reached agreement on the design of our Phase 3 trials after a six-month long Special Protocol Assessment (SPA) process. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trial are acceptable to support regulatory approval by the FDA.
On August 15, 2017, the FDA granted Breakthrough Therapy Designation (BTD) to MDMA-assisted psychotherapy for the treatment of PTSD. FDA rejects about two-thirds of applications for BTD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. BTD also means that the FDA will work closely with MAPS to conduct the development program as efficiently as possible and to plan ahead of time regarding issues of commercialization should Phase 3 studies prove successful.
MAPS and MPBC staff are excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted psychotherapy. Donations are currently being sought to reach MAPS’ goal of raising $26.7 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021. With $26.2 million in hand or in multi-year pledges, there’s still a funding gap we need to close. Approval from the European Medicines Agency (EMA) will require additional funds so MAPS is starting to try to raise $5 million for our EMA research. MAPS began negotiations with EMA on March 1, and will travel to London, United Kingdom, to meet with EMA in Summer 2018. Learn more…