On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended alone or in combination with …
On June 22, 2017, MAPS submitted to the U.S. Food and Drug Administration (FDA) an application for Breakthrough Therapy designation for our upcoming Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic …
On June 13, as part of FDA’s Special Protocol Assessment process, MAPS submitted to FDA a revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The …
On May 11, 2017 MAPS and MPBC staff held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD. At the …
