FDA rejects MDMA

Lykos Therapeutics faced a setback as the FDA rejected its application for MDMA-assisted therapy for PTSD, citing the need for additional research, specifically another Phase 3 trial to further assess safety and efficacy. CEO Amy Emerson expressed disappointment, emphasizing the urgent need for new treatment options for the millions suffering from PTSD. The FDA's decision aligns with concerns raised by its advisory committee regarding the validity of the clinical research and potential biases in the trial's design. This rejection comes amid growing interest in psychedelic treatments, with advocates urging for innovative solutions for veterans and others affected by PTSD. Lykos plans to request a meeting with the FDA to discuss potential reconsideration and address the agency's concerns. The outcome could have wider implications for the approval of other psychedelic-based therapies on the horizon.