Therapy using MDMA, also known as ecstasy or molly, for treating post-traumatic stress disorder (PTSD) in the United States faced a setback as advisers to the country’s health regulator opposed it.
In a 10-1 vote, advisers to the Food and Drug Administration (FDA) expressed doubts about the overall benefits of using MDMA to treat PTSD. Nine out of the 11 advisers highlighted that the available data didn’t demonstrate the drug’s effectiveness in PTSD patients.
The vote came after reviewing research presented by Lykos Therapeutics, suggesting that MDMA therapy, coupled with talk therapy sessions by licensed mental health providers, could be beneficial. One trial indicated that 71% of the treatment group no longer met PTSD criteria, compared to 48% in a placebo group.
However, panelists raised several concerns regarding the data. These included doubts about the treatment’s long-lasting benefits, issues with the study designs, and potential risks like heart problems, injury, and abuse.
Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, commented, “It seems like there are so many problems with the data. Each one alone might be okay, but when you pile them on top of each other… there’s just a lot of questions I would have about how effective the treatment is.”
The FDA isn’t bound to follow the committee’s votes, but it often considers the panel’s feedback. A final decision is anticipated by August 11.
Last year, Australia’s medicines regulator, typically conservative, approved the use of drugs, including MDMA, to aid therapy sessions.
