MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks.
On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress disorder, based on positive phase 3 results demonstrating significant PTSD reductions for most trial participants. In the studies, a significant number of those receiving MDMA-assisted therapy no longer qualified for a PTSD diagnosis after three treatment sessions, with a large majority seeing clinically meaningful improvements.
Currently, the Drug Enforcement Administration (DEA) categorizes MDMA as a Schedule I controlled substance having no approved medical uses, although it is likely to reclassify the stimulant if it receives FDA approval.
MAPS founder Ric…