FDA panel votes against MDMA for PTSD therapy

The prospect of MDMA being used to treat post-traumatic stress disorder (PTSD) in the United States has hit a setback after advisers for the country’s health regulator voted against therapy using the party drug.

MDMA – commonly known as ecstasy or molly – has been touted as having therapeutic benefits for people suffering from some mental health disorders.

But advisers to the Food and Drug Administration (FDA) voted 10-1 against the overall benefits of MDMA when used to treat PTSD.

Nine of the 11 said the available data did not show the effectiveness of the drug in PTSD patients.

The vote followed analysis of research by drugmaker Lykos Therapeutics, which advised that treatment be administered in combination with talk therapy sessions by a licensed mental health provider.

One of its trials found 71% from the treatment group no longer met PTSD criteria, compared to 48% from a group taking a placebo.

But panellists voiced numerous concerns with the data.

Issues included that the treatment may not offer long-lasting benefits, concerns about the ways the studies were designed, and the potential risk for heart problems, injury and abuse.

“It seems like there are so many problems with the data,” Dr Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, told the Associated Press.

“Each one alone might be OK, 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 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.