MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
We have a long history of supporting qualified healthcare providers seeking to deliver investigational MDMA-assisted therapy in clinical trials for people with post-traumatic stress disorder (PTSD) and other mental health conditions. We have worked hard to provide a space for learning and exploration of this innovative new field of study. With our Phase 3 clinical trials now complete and our new drug application submitted, we are moving into the next phase of our work. We are focusing our efforts on designing a therapy training program, should we receive U.S. Food and Drug Administration (FDA) approval of MDMA-assisted therapy. We intend to build a robust quality program based on decades of research and best practices in training and education programs. Our goal is to help ensure that if approved, therapists have the proper training to deliver MDMA-assisted therapy in accordance with our clinical trial protocol.