Public announcement from FDA

FDA Panel Votes 9-2 Against MDMA for PTSD Treatment Citing Safety Concerns

Jun 4, 2024, 09:33 PM

A U.S. Food and Drug Administration (FDA) advisory panel has voted overwhelmingly against recommending the approval of MDMA, commonly known as ecstasy, for the treatment of post-traumatic stress disorder (PTSD). The panel cited significant concerns regarding the safety and validity of clinical trial data presented by Lykos Therapeutics, the company developing the treatment. Key issues included study bias, safety concerns such as liver toxicity, and the potential for unblinding due to the noticeable effects of MDMA. The psychotherapy component, which the FDA does not regulate, was also a point of contention. The panel's decision, with a vote of 9-2 against the drug's efficacy and 10-1 against its safety, represents a significant setback for advocates of psychedelic therapies. During the meeting, more than 30 people spoke in the public comment section. Despite the rejection, the FDA will make a final decision in mid-August.