FDA denies approval for MDMA therapy for PTSD ...Middle East

The Food and Drug Administration (FDA) on Friday denied approval to an MDMA-based treatment for post-traumatic stress disorder, the manufacturer said, a major setback for the use of psychedelic drugs as medicine. Drug company Lykos Therapeutics said the FDA told them the treatment "could not be approved based on data submitted to date." Lykos said the FDA has requested an additional Phase 3 trial to further study the safety and efficacy of the treatment, but such studies often take years. The company said it plans to request a meeting with the FDA to ask for reconsideration. "The FDA request for another study is deeply disappointing, not just for all those who dedicated their liv

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