MAPS Public Benefit Corporation on Tuesday announced it has filed a New Drug Application with the United States Food and Drug Administration (FDA) for MDMA-assisted therapy in patients with post-traumatic stress disorder (PTSD) which, if approved, would mark the first psychedelic-assisted therapy.
With the FDA granting MDMA Breakthrough Therapy designation in 2017, the company has requested a priority Review of the NDA.
According to MAPS PBC, the FDA has 60 days to determine if the NDA will be accepted for review and if its review will be priority or standard, taking six months or 10 months respectively.
Should the NDA be approved, the Drug Enforcement Agency would need to reschedule MDMA to make it available for prescription medical use.
The NDA follows numerous studies including two late-stage studies evaluating the efficacy and safety of MDMA-assisted therapy.
"The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades," MAPS PBC CEO Amy Emerson said in a statement.
"If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health."
The news did not prompt a rally in psychedelics stocks, with the Advisorshares Psychedelics ETF traded down 0.7% at US$1.28 and the Horizons Psychedelic Stock Index ETF was down 0.8% at C$4.92 in the early afternoon on Tuesday.