FDA panel votes against MDMA for PTSD therapy

[Pelican Press 0]

FDA panel votes against MDMA for PTSD therapy

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

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 ***** 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 ***** 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 ******.

“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 ************* medicines regulator approved the use of drugs – including MDMA – to assist therapy sessions.

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