The Food and Drug Administration (FDA) says it will consider approval of psychedelic drug MDMA to be used in therapy for post-traumatic stress disorder (PTSD).
If FDA approves the drug, also known as ecstasy, it would mark the first psychedelic-assisted therapy approved for PTSD and follows more than 30 years of clinical research, according to a Multidisciplinary Association for Psychedelic Studies (MAPS) announcement Tuesday.
MAPS said it requested the FDA grant priority review of its new drug application. If granted, the FDA would need to hand down a decision within six months. Otherwise, the FDA has 10 months to make a decision.
Amy Emerson, the CEO of MAPS, said the organization hopes such approval will “drive additional investment investment into new research in mental health.”
MDMA is among a class of psychoactive drugs that can lead to experiences of “emotional communion, oneness, relatedness and emotional openness,” according to MAPS.
MDMA was used in the 1970s with psychotherapy by mental health providers to help patients process certain emotions and experiences, but in 1985, the Drug Enforcement Agency (DEA) made MDMA a Schedule I drug under the Controlled Substances Act, which prevented it from medical use, MAPS said.
MAPS pointed to two studies it conducted that met its targeted outcomes.
Approval by the FDA does not mean MDMA will immediately start being used in practice, as state medical boards often grant the right to practice medicine.
Mason Marks, a senior fellow at the Project on Psychedelics Law and Regulation at Harvard Law School told The Washington Post that FDA approval could come with “some significant restrictions” on who can prescribe MDMA and which pharmacies or facilities will be able to distribute the drug.
He added he does not believe it will be a “quick turnaround,” and the facilities may also be asked to designate space and supervision over a certain amount of time for a patient taking MDMA, the Post reported.
