Phase 3: MAPS Prepares to Request Breakthrough Therapy Designation and Special Protocol Assessment

On December 13, 2016, the U.S. Food and Drug Administration (FDA) participated in a teleconference with MAPS to discuss whether we should apply for Breakthrough Therapy Designation for MDMA-assisted psychotherapy as a treatment for posttraumatic stress disorder (PTSD). “It was a very helpful meeting, and we were encouraged to proceed with applying for Breakthrough Therapy Designation,” explains MAPS-sponsored researcher Michael Mithoefer, M.D.

If approved, Breakthrough Therapy Designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD. According to the FDA, a breakthrough therapy is intended “to treat a serious or life threatening disease condition,” and “may demonstrate substantial improvement over existing therapies.”

In the next few weeks, we will also submit to the FDA our Phase 3 trial protocol for the Special Protocol Assessment (SPA) process. The SPA process is a rigorous review of the Phase 3 trial design that could result in FDA committing to approve MDMA-assisted psychotherapy for PTSD should the protocol as designed prove safety and efficacy.

As a non-profit with no government funding for MDMA research, we anticipate it will cost between $25-$30 million to complete these Phase 3 trials over the next five years, with over $10 million already raised or pledged. Phase 3 trials are the final stage of research needed before the FDA 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…