Research: Current Focus
Phase 3 Trials Regulated by European Medicines Agency (EMA)
On June 12, 2018, MAPS met in London with the Scientific Advice Working Party of the European Medicines Agency (EMA). On June 28, MAPS received written scientific advice about its Phase 3 protocol and overall drug development plans, with approval to proceed to a Phase 3 trial in Europe. MAPS has also applied for the EMA equivalent of Breakthrough Therapy, known as PRIME. EMA Phase 3 trials are anticipated to start in the summer of 2019, pending funding and regulatory approval by individual European countries. MAPS has raised $27 million in donations for Phase 3 trials for FDA. Since EMA agreed to accept for review the data that MAPS is gathering for FDA, estimated costs for Phase 3 for Europe are only $9 million, of which MAPS has already raised $900,000.
European Medicines Agency Study Design
MAPS’ proposed sample size for the European Phase 3 trial is 70 PTSD patients across nine study sites, with half of participants receiving manualized therapy with inactive placebo and half receiving manualized therapy with MDMA.
Based on scientific advice from EMA, MAPS aims to ensure cross-cultural validity of the research by including geographically diverse sites. In addition, EMA requested the inclusion of migrants and refugees with PTSD.
FDA Drug Development Progress
In 2016, 30 years after after its founding, MAPS completed an international series of six Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD. In these studies, preliminary evidence in over 100 subjects with chronic, treatment-resistant PTSD suggested the treatment was effective and well tolerated. These studies supported FDA and EMA expansion into Phase 3 trials and led to the FDA granting Breakthrough Therapy designation for MDMA-assisted psychotherapy for PTSD. In November 2018, MAPS will initiate a large-scale, multi-site Phase 3 trial for MDMA-assisted psychotherapy for PTSD at up to 16 sites to enroll 200-300 participants across the U.S., Canada, and Israel. The data will support a New Drug Application (NDA) to FDA, and will also support the Marketing Authorization Application (MAA) for EMA.
Phase 2 MDMA-Assisted Psychotherapy for PTSD Results
In the pooled data from the six Phase 3 trials, significant symptom reductions were seen in a large sample of participants with chronic, treatment resistant PTSD following MDMA-assisted psychotherapy. Over 2/3 of the subjects no longer qualified for a diagnosis of PTSD at the 12-month follow-up after the last MDMA-assisted psychotherapy session. The effectiveness of the treatment was not dependent on the cause of PTSD, demonstrating the generalizability of this treatment approach.
EMA Phase 3 trials are scheduled to start late in the summer of 2019.
MAPS is currently seeking $9 million for EMA trials, with $900,000 already raised. MAPS will continue to raise funds from donations while serving as parent organization and sole shareholder of MAPS PBC and MAPS Europe. Both MAPS PBC and MAPS Europe are key parts of MAPS’ strategy to become a sustainable non-profit organization through reasonable profits from sales of MDMA by prescription.
Please be advised that the MAPS Europe B.V. Board of Directors has established a published policy of limiting indirect overhead expenses to 10% of direct costs.