MAPS Public Benefit Corp. filed an application on Tuesday with the U.S. Food and Drug Administration to approve the psychedelic drug MDMA — also known as Ecstasy — in combination with therapy to treat post-traumatic stress disorder, in what would be the first treatment of its kind.
The filing is a milestone in researchers’ quest to move psychedelic drugs from tightly restricted substances into mainstream medical treatments that are widely accessible to patients. It comes after decades of studies have demonstrated the promise of psychedelics — including psilocybin, or magic mushrooms, and ketamine — to treat mental health disorders.
“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,” Amy Emerson, chief executive of MAPS, said in a statement Tuesday. MAPS is seeking a priority review from the FDA that could yield a determination within six months.
FDA approval, while by no means assured, could raise tricky issues for regulatory authorities. The FDA doesn’t regulate the practice of medicine, which is generally left to state licensing boards. It isn’t yet clear to what extent authorities will address who is authorized to provide therapy and the question of doctors potentially prescribing MDMA for different conditions, known as off-label use.
Emerson said in a September interview that she expected that, if the treatment is approved, an FDA label would say the treatment “needs to be implemented in the way it was studied” — with a therapy component.
