MDMA Therapy Training Program: Expanded Access Update

The MDMA Therapy Training Program is currently preparing researchers to work on Phase 3 clinical trials researching MDMA-assisted psychotherapy for Posttraumatic Stress Disorder (PTSD). These 82 therapists are in the midst of our supervision program, which will be an integral part of our training program going forward. Phase 3 trials are starting Summer 2018 in the United States, Canada, and Israel. The results of the Phase 3 studies will support a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), to make MDMA-assisted psychotherapy into a legal prescription medicine, anticipated to take place in 2021.

Later this year, MAPS plans to apply for a special FDA program called Expanded Access, which allows the use of an investigational treatment outside of a clinical trial. The program’s purpose is to grant access to potentially beneficial investigational treatments for individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. Learn more about Expanded Access on the FDA’s website.

If Expanded Access is approved, new sites meeting the requirements below can seek approval to be part of MPBC’s multi-center Expanded Access protocol, which will allow them to administer open-label MDMA-assisted psychotherapy for PTSD. Qualified therapist applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy, with approval by regulatory agencies.

An online application for potential Expanded Access sites and their therapy providers will be posted in late 2018. Since Expanded Access is a US FDA program, only sites in the US and US territories may participate. If you would like to receive updates about the MDMA Therapy Training Program and Expanded Access plans, as well as learn about upcoming requirements for Expanded Access sites and providers, please sign up online for our training newsletter. Learn more…