On January 23, 2017, the U.S. Food and Drug Administration (FDA) confirmed their receipt of MAPS’ protocol for Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The FDA allots 45 days to complete their Special Protocol Assessment (SPA) process, which is a rigorous review of the Phase 3 trial design that could result in the FDA committing to approve MDMA-assisted psychotherapy for PTSD should the protocol as designed provide sufficient evidence proving safety and efficacy.
We expect to initiate our first Phase 3 clinical trial in the second half of 2017, which will last 2-3 years and enroll at least 200 participants. As a non-profit with no government funding yet for MDMA research, we anticipate it will cost between $25-$33 million over the next five years to complete two Phase 3 trials, seeking approval from both the FDA and the European Medicines Agency (EMA). Over $10 million has already been raised or pledged. Phase 3 trials are the final stage of research needed before the FDA and EMA will decide whether to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Learn more…
