Midomafetamine, or MDMA, a form of molly or ecstasy that has increasingly been coupled with patient therapy to treat post-traumatic stress disorder, was approved recently for a fast-track review by the U.S. Food and Drug Administration, according to a Feb. 9 announcement from Lykos Therapeutics.
The designation means the FDA will review the drug on a faster timeline — six months instead of 10 — and “direct overall attention and resources” to the study of drugs that, if approved, would allow for “improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions,” according to the FDA’s website.
The FDA has a target date of Aug. 11 to conclude its evaluation of MDMA-assisted therapy. Lykos Therapeutics filed for the review.
“We’re grateful to those in Washington, D.C., who are working overtime to pave the way for [MDMA]’s acceptance and approval,” Juliana Mercer, director of veteran advocacy for the group Healing Breakthrough, said in a statement. “The federal government is putting skin in the game after decades of philanthropically-funded private research.”
The FDA in 2017 designated MDMA as a “breakthrough therapy” for treatment of PTSD. Psilocybin to treat anxiety and depression received that designation in 2019.
The Multidisciplinary Association of Psychedelic Studies, or MAPS, has researched the effects of MDMA for more than 30 years. It was tasked with conducting further studies on the treatment, the most recent of which was a multisite clinical trial and a second phase III trial.
In the second trial, more than 86% of participants who received the MDMA-assisted therapy for PTSD experienced “clinically meaningful” improvement 18 weeks after starting the trial, according to MAPS.
More than 71% of participants who underwent MDMA-assisted therapy also no longer met the diagnostic criteria for PTSD at the end study, compared to little more than 46% of participants who had the placebo plus therapy.
The first-ever provision for psychedelic studies was passed last year in the 2024 defense policy bill. Though yet to be passed, the Veterans Affairs appropriations bill would direct the department to set up pilot programs across the country for breakthrough therapies, including MDMA.
Zamone “Z” Perez is a reporter at Military Times. He previously worked at Foreign Policy and Ufahamu Africa. He is a graduate of Northwestern University, where he researched international ethics and atrocity prevention in his thesis. He can be found on Twitter @zamoneperez.
