An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.
A dose of MDMA from the MAPS Public Benefit Corp., which is now renamed as Lykos Therapeutics, a for-profit company whose studies the F.D.A. is analyzing.
Developed in 1912, MDMA was reclassified in 1985 as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.
The agencyβs staff analysis suggests that approval of the illegal drug known as Ecstasy for treatment of PTSD is far from certain, with advisers meeting next week to consider the proposed therapy.
A seizure of the drug MDMA, known as Ecstasy or molly. It and other psychoactive drugs are still classified as illegal drugs with a potential for abuse.
The prevalence of post-traumatic stress disorder among college students rose to 7.5 percent in 2022, more than double the rate five years earlier, researchers found.