The First and Only to Sponsor a Phase 3 Clinical Trial with MDMA
After preliminary studies demonstrated the safety and efficacy in the treatment of posttraumatic stress disorder (PTSD), the Food and Drug Administration (FDA) granted Breakthrough Therapy designation for MDMA.
Find out more about enrollment in our clinical trials.
What is MDMA?
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that have the potential to:
- Treat a serious, life-threatening illness and
- Demonstrate a benefit over available therapies
A drug that receives Breakthrough Therapy designation is eligible for the following:
- More frequent communication with FDA regarding treatment approval requirements and a rolling New Drug Application review (all Fast Track designation features)
- Intensive guidance on an efficient drug development program, beginning as early as Phase 1
- Organizational commitment involving senior managers from the FDA
Breakthrough Therapy Designation – A Major Breakthrough
MDMA Is Now in Phase
3 Clinical Trials
For each participant, the study will consist of:
- Screening and enrollment of eligible participants
- Preparatory sessions and baseline assessments
- Treatment period:
- three monthly blinded experimental sessions and associated non-drug integrative sessions over ~12 weeks
- Follow-up period and study termination
- Four weeks with no study visits followed by assessments and the study termination visit
- Invitation to participate in 12-month follow-up extension study to determine long-term effects of treatment
- Individuals in the placebo group invited to participate in an open-label MDMA study with a similar study design
Once the study blind is broken and participants know which treatment they received, all participants in the placebo group will be offered the opportunity to enroll at no cost in an open-label extension study to receive the exact same treatment of MDMA-assisted therapy as in the initial study. Data will be included in MAPS’ overall safety database.
Six Phase 2 trials suggest – Safe and effective in reducing the symptoms of PTSD
Trial Design: Randomized, double-blind, dose-response, phase 2 trials at an outpatient psychiatric clinics in the USA, Canada, and Israel.
Study Participants: Adults with chronic PTSD lasting 6 months or longer, and who had a Clinician-Administered PTSD Scale (CAPS-IV) total score of 60 or greater.
“If results of the first two Phase 3 studies are statistically significant and no safety concerns are identified, these would be the only Phase 3 studies needed for FDA approval.”
– Amy Emerson, MAPS PBC Executive Director & Head of Clinical Development and Regulatory Affairs