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News|Videos|August 8, 2024
As FDA Decision on MDMA for PTSD Looms, What Would Approval Mean for Mental Health Treatment?
Author(s)Killian Meara
Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.
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The FDA’s decision on a new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) is quickly approaching, with a Prescription Drug User Fee Act (PDUFA) date set for August 11. The agency’s verdict has been highly anticipated and could mark a historic shift in psychedelic medicine, as it would be the first psychedelic-assisted therapy approved in the United States.
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