Phase 3 Trials: MAPS Meets with European Medicines Agency (EMA)

On June 12, 2018, MAPS had a successful meeting in London, United Kingdom, with the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA). The discussion focused on scientific advice for the clinical development of MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD). Data gathered in European trials would provide support for a planned Marketing Authorization Application for EMA.

Key notes:

  • MAPS’ efforts to work with the EMA are moving forward well
  • MAPS will likely to be able to move to Phase 3 MDMA research in Europe
  • We will need increase the number of subjects and countries for Phase 3 research in the EU
  • EMA research is more complex that FDA research
  • MAPS will host a training for European therapists from September 27 – October 3, 2018.
  • EMA Phase 3 is scheduled to start late in the summer of 2019

The U.S. FDA-regulated Phase 3 trials starting in August 2018 will assess the efficacy and safety of MDMA-assisted psychotherapy in adult participants with PTSD at up to 16 sites in the U.S., Canada, and Israel. Over a 12-week treatment period, participants will be randomized to receive twelve non-drug preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart of either MDMA or placebo in conjunction with psychotherapy. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.

The trials are the final phase of research required by the FDA before deciding whether to approve MDMA as a legal prescription treatment for PTSD. If approved, MDMA will be required to be used in conjunction with psychotherapy in an outpatient setting with a residential stay. Learn more…