FDA Advisors Recommend Against Using MDMA for PTSD Treatment

Members of the FDA’s Psychopharmacologic Drugs Advisory Committee said that they did not feel there is sufficient evidence to show that the drug is effective in a 9-2 vote. In a 10-1 vote, experts overwhelmingly said that the benefits of MDMA, commonly known as ecstasy or molly, do not outweigh the risks.

The panel was tasked with evaluating a proposed treatment developed by Lykos Therapeutics, which involves taking prescribed doses of MDMA under the supervision of clinicians providing psychotherapy to treat patients with moderate to severe PTSD. The FDA does not have to abide by the panel’s guidance, but does take its input into consideration. The FDA will announce whether the drug is approved for use in PTSD treatment by Aug. 11.

"We are disappointed in today's vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy and psychological intervention," said Lykos Therapeutics CEO Amy Emerson in a Tuesday.

have difficulty falling asleep, feel irritable, have trouble remembering what happened during the event, socially isolate, and more. , though there is no exact number on how many people have PTSD. The Center says people are more likely to be at risk of PTSD if they’ve experienced war, natural disasters, or a pandemic. Veterans are alsoantidepressants for the treatment of PTSD.

said patients could be at “risk for serious harm resulting from patient impairment” if they took MDMA. The FDA also expressed concern about potentially worsening other psychological disorders due to the effects of the drug, which could lead to death, orIn the late 1970s to early ‘80s, some psychiatrists began to believe that MDMA helped patients communicate and “achieve insights about their problems,”.

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