FDA to consider psychedelic-assisted therapy for PTSD

The Food and Drug Administration (FDA) has announced that it will consider approving the hallucinogen MDMA used to treat post-traumatic stress disorder (PTSD).

If the FDA approves the drug, also known as ecstasy, it would be the first psychedelic adjuvant therapy approved for PTSD after more than 30 years of clinical research, according to a Tuesday announcement from the Multidisciplinary Association for Psychedelic Studies (MAPS). It is said to become.

MAPS said it has asked the FDA to grant priority review of the new drug application. If approved, the FDA would have to make a decision within six months. Otherwise, the FDA requires him to make a decision within 10 months.

Amy Emerson, CEO of MAPS, said the organization hopes these approvals will “spur additional investment in new research in mental health.”

According to MAPS, MDMA is a psychoactive drug that can lead to “a sense of emotional interaction, togetherness, relatedness, and emotional openness.”

MDMA was used in the 1970s in conjunction with psychotherapy by mental health care providers to help patients process certain emotions and experiences, but in 1985 the Drug Enforcement Administration (DEA) classified MDMA under the Controlled Substances Act. It is now a Schedule I drug and has no medical use. said MAPS.

the map points in two studies that carried out to satisfy its desired outcome.

Approval by the FDA does not mean that state medical boards will immediately begin using MDMA in practice. often give rights To practice medicine.

Mason Marks, Senior Fellow, Psychedelic Law and Regulation Project, Harvard Law School told the Washington Post The FDA's approval could come with “some significant restrictions” on who can prescribe MDMA and which pharmacies and facilities can distribute the drug, he said.

He added that he did not believe it would be a “quick fix,” and that facilities could be asked to designate a space for patients taking MDMA and provide a period of supervision. , the Post reported.