FDA Denies MDMA for PTSD Use, Seeks More Trials

The U.S. Food and Drug Administration (FDA) has rejected an application from Lykos Therapeutics to use MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD). The agency has requested an additional Phase 3 trial to further evaluate the safety and efficacy of the treatment, despite positive data from two late-stage clinical trials that involved around 200 participants. These trials combined MDMA with talk therapy, featuring three eight-hour sessions under the supervision of two therapists. While the initial trials showed promise, FDA committee members expressed concerns regarding incomplete safety assessments and potential biases in the efficacy data. The trials indicated significant increases in blood pressure and pulse among participants, raising alarms about the treatment's safety profile. Lykos Therapeutics acknowledged that conducting the additional trial could take years but remains optimistic about addressing the FDA's concerns. The decision comes at a time when approximately 13 million adults in the U.S. experience PTSD annually, with current treatment options proving limited in effectiveness. Public Citizen, a nonprofit consumer advocacy group, supported the FDA's decision, arguing that a cautious approach is necessary for such a novel treatment. Critics, including veterans' advocates, lamented the outcome, suggesting that it forces veterans to seek MDMA-assisted therapy through underground channels or abroad, highlighting a significant gap in accessible mental health care.