FDA Agrees To Expanded Access Program For MDMA-Assisted Psychotherapy For PTSD

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the U.S. Food and Drug Administration (FDA) has approved MAPS’ application for an Expanded Access program for MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD). The purpose of the Expanded Access program is to allow early access to potentially beneficial investigational therapies for people facing a serious or life-threatening condition for whom currently available treatments have not worked, and who are unable to participate in Phase 3 clinical trials.

On December 20, 2019, the FDA notified MAPS that it may proceed with its Expanded Access protocol . . .