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

[Grim Reaper 6]

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 took MDMA in the presence of two therapists. The MDMA sessions were spaced about a month apart, along with additional talk therapy sessions.

MDMA is an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness and emotional openness..

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