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 (PTSD). The decision came after drug sponsor Lykos Therapeutics received a request from the agency for an additional Phase 3 trial to further study the safety and efficacy of the treatment.
MDMA, an entactogen that produces experiences of emotional communion and openness, was used in combination with talk therapy in two late-stage clinical trials conducted by Lykos. The trials involved about 200 participants who underwent three eight-hour sessions spaced a month apart, where they took MDMA in the presence of two therapists.
