MDMA Phase 3 Trials: FDA and DEA Host Breakthrough Therapy Meetings

On Monday, December 18, MAPS’ clinical team met with our pro-bono pharmaceutical lawyer, Peter Barton Hutt of Covington & Burling. On Tuesday, December 19, MAPS’ clinical team leaders, Executive Director, and U.S. Drug Enforcement Administration (DEA) consultant met with the DEA at their headquarters in Arlington, Virginia. The discussion focused on streamlining plans for Schedule I licenses for researchers and potential Expanded Access therapists.

On Wednesday, December 20, 17 staff from the U.S. Food and Drug Administration (FDA) met with MAPS researchers and staff from MAPS Public Benefit Corporation (MPBC) at FDA’s White Oak Campus in Silver Spring, Maryland. This was our first meeting under the Breakthrough Therapy Designation program to discuss various issues related to our Phase 3 clinical trials and potential prescription approval of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).

MAPS Public Benefit Corporation (MPBC) clinical research staff have completed 11 of 14 Study Initiation Visits for an open-label lead-in study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at planned Phase 3 sites across the United States and Canada. These Study Initiation Visits provide training on study procedures to clinical trial sites that will receive clinical supervision of MDMA-assisted psychotherapy in preparation for Phase 3.

Starting at some Phase 3 sites now and continuing until June 2018, we will conduct the open-label lead-in training study. We will enroll 1-4 participants per site. 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 Phase 3 trials starting next year 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.

Enrollment is expected to start in the summer of 2018 in the following locations:

  • Los Angeles, CA | private practice
  • San Francisco, CA | research institution
  • San Francisco, CA | private practice
  • Boulder, CO | private practice
  • Fort Collins, CO | private practice
  • New Orleans, LA | private practice
  • New York, NY | research institution
  • New York, NY | private practice
  • Charleston, SC | private practice
  • Madison, WI | research institution
  • Boston, MA | research institution
  • Montreal, Canada | private practice
  • Vancouver, Canada | research institution
  • Tel Aviv, Israel | research institutions

The trials build 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, required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay.

On July 28, 2017, MAPS and the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that 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 million to successfully execute the Phase 3 studies required to gain approval from the FDA for MDMA-assisted psychotherapy by 2021, with approval from the European Medicines Agency (EMA) possibly requiring additional funds. With $15.5 million in hand or in multi-year pledges, there’s still a funding gap we need to close. Learn more…