Maker of MDMA-assisted PTSD treatment to seek US regulatory nod

[September 15, 2023]   (Reuters) - The Multidisciplinary Association for Psychedelic Studies (MAPS) plans to file for regulatory approval for the party drug MDMA as a treatment for post-traumatic stress disorder in the United States later this year, in a potential boost to the nascent psychedelic therapeutics industry.

A woman retrieves items from the rubble of her destroyed home after a wildfire came through the area in Talent, Oregon, Oregon, U.S. September 21, 2020. REUTERS/Jim Urquhart/File photo

PTSD is a disorder caused by very stressful events and can significantly disrupt patients' lives. MDMA, used in the drug Ecstasy, is currently illegal in the U.S.

MAPS, a nonprofit, said it would file an application with the U.S. Food and Drug Administration based on data from 18 mid- and late-stage clinical trials, according to a statement published on Thursday.

The decision to seek approval comes after data from a second late-stage study of nearly 100 patients, also published on Thursday, showed that MDMA coupled with therapy helped 71.2% of patients no longer qualify for a PTSD diagnosis, versus 46.2% of patients on a placebo.

While PTSD is commonly associated with combat, civilians are not immune to it. Natural disasters, abuse or other trauma may trigger the condition.

Psychoactive ingredients, whether derived from cannabis, LSD or magic mushrooms, have long captivated mental health researchers in their quest for treatments. MAPS, founded in 1986, said it hopes the MDMA-assisted therapy will be approved next year and inspire other researchers studying therapeutic psychedelics.

No psychedelic-based therapy has been approved yet in the U.S., but MAPS and companies like Compass Pathways are testing such drugs to find cures for a range of mental health disorders.

(Reporting by Manas Mishra in Bengaluru; Editing by Pooja Desai)

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