In a press release dated 26 August 2017, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the US Food and Drug Administration has granted ‘Breakthrough Therapy’ designation for MDMA-assisted psychotherapy for PTSD.
The FDA grants Breakthrough Therapy designation to treatments that preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Read the full press release here.
