US expert panel votes against MDMA therapy
The potential for MDMA to be used in treating post-traumatic stress disorder (PTSD) in the United States has encountered a setback after advisers to the country’s health regulator voted against its therapeutic use.
Known as ecstasy or molly, MDMA has been suggested to have benefits for mental health disorders. However, the Food and Drug Administration (FDA) advisers voted 10-1 against endorsing MDMA for PTSD treatment.
Nine out of 11 advisers expressed that the current data did not sufficiently demonstrate the drug’s effectiveness for PTSD patients. This decision followed an analysis of research by Lykos Therapeutics, which recommended combining MDMA treatment with talk therapy sessions conducted by a licensed mental health provider.
In one trial, 71% of the treatment group no longer met the criteria for PTSD, compared to 48% in the placebo group. Despite this, panelists raised several concerns about the data, including the potential for non-lasting benefits, issues with study design, and risks of heart problems, injury, and abuse.
Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, commented to the Associated Press, “There seem to be so many problems with the data. Each one alone might be okay, but combined, they raise a lot of questions about the treatment’s effectiveness.”
The FDA is not required to follow the committee’s votes, but the agency often follows the panel’s feedback.
A final decision is expected by 11 August.
Last year, Australia’s traditionally conservative medicines regulator approved the use of drugs – including MDMA – to assist therapy sessions.
