European Medicines Agency (EMA) to Host Meeting with MAPS

On June 12, 2018, MAPS will meet with the European Medicines Agency (EMA) in London, United Kingdom, to discuss 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.

On May 24, 2018, Clinical Research Associate, Gabrielle Fortier, M.P.H., of the MAPS Public Benefit Corporation (MPBC), conducted a Study Initiation Visit for a Phase 3 study of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) at the planned Phase 3 site in Fort Collins, Colorado. A Study Initiation Visit for the Boulder, Colorado study site is scheduled for June 13, 2018.

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 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. Learn more…