FDA advisers reject MDMA therapy to treat PTSD

FILE-Two MDMA pills are pictured on a table. (Photo by Andrew Lichtenstein/Corbis via Getty Images)

Food and Drug Administration advisers voted to reject using MDMA as a treatment for post-traumatic stress disorder. 

The panel cited insufficient study data, questionable research conduct, and drug risks like the potential for heart problems, injury, and abuse. 

Panel members on Tuesday also pointed to allegations of impropriety occurring during clinical trials that were reported in news stories and by the Institute for Clinical and Economic Review, a nonprofit organization that examines experimental drug treatments. 

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These incidents included a 2018 report of alleged sexual misconduct by a therapist and her husband while treating a patient, the Associated Press noted. 

Lykos Therapeutics, the company behind the MDMA study, said it previously reported the incident to the FDA and regulators in Canada, where the therapist is located.

Panelists also noted the difficulty of knowing how much of patients’ improvement came from MDMA versus simply undergoing the extensive therapy.

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Separately, multiple public speakers addressed the FDA panel including veterans who stated MDMA therapy helped them.

What is MDMA?

MDMA, which is sometimes called ecstasy or molly, is the first in a series of psychedelic drugs — including LSD and psilocybin — that are expected to come before the FDA for review in the next few years as part of a revival of interest in the drugs’ medical potential, which supporters believe could transform the treatment of mental health disorders, the Associated Press reported. 

MDMA doesn't cause the visual hallucinations commonly associated with psychedelics. However, its main effect triggers feelings of intimacy, connection, and joy. 

When the drug is used to enhance talk therapy, it appears to help patients process their trauma and let go of disturbing thoughts and memories.

Because MDMA causes intense, psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a fake pill.

The FDA is not required to follow the panel’s advice and is expected to make its final decision by August.

The Associated Press contributed to this report.  This story was reported from Washington, D.C.