Quick Hits: FDA Could Approve MDMA as Early as Next Year

A recent New York Post article discussed a new regulatory advancement for MDMA. The drug, commonly known as ecstasy or molly, is a psychoactive drug primarily known for recreational use. However, years of research and clinical trials have shown the drug can be an effective treatment for post-traumatic stress disorder (PTSD). The Multidisciplinary Association for Psychedelic Studies (MAPS) announced they have received “expanded access” approval from the FDA to continue research that could likely lead to the legalization of MDMA for medical purposes.

“We’re looking at possible FDA approval for treatment at the end of 2021, and the accessibility of treatment in clinics by 2022,” said a spokesperson for MAPS. MDMA-assisted psychotherapy has proven so effective that the FDA issued a Special Protocol Assessment, which means that if Phase 3 trials are successful, the therapy will be approved.