FDA declines to approve novel MDMA therapy to treat PTSD, with request for more trial data ...Middle East

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FDA declines to approve novel MDMA therapy to treat PTSD, with request for more trial data
By Deidre McPhillips, CNN (CNN) — The US Food and Drug Administration has declined to approve an application for the use of MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder, according to a news release from drug sponsor Lykos Therapeutics. The company says the agency has requested an “additional Phase 3 trial to further study the safety and efficacy” of the treatment. The initial application from Lykos presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD. About 200 people participated in the Lykos trials, with a treatment program that involved three eight-hour sessions in which they to

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