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FDA declines to approve novel MDMA therapy to treat PTSD, with request for more trial data
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 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. Read More Breaking News, Latest News and Videos | CNN