Lykos psychedelic treatment for PTSD rejected by FDA

Lykos Therapeutics announced last night that the Food and Drug Administration issued a complete response letter for the new drug application for midomafetamine capsules for the treatment of post-traumatic stress disorder in adults. The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date, the company said in a statement. The FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine. Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations for a resubmission seeking regulatory approval for midomafetamine capsules. “The issues expressed in the CRL echo those raised during the FDA Advisory Committee meeting on June 4, 2024. The Company and other stakeholders have expressed concerns around the structure and conduct of the Advisory Committee meeting, including the limited number of subject matter experts on the panel and the nature of the discussion, which at times veered beyond the scientific content in the briefing documents. FDA itself has acknowledged potential problems with the Advisory Committee process and has opened a public docket seeking comments on how it can be improved,” Lykos added. Other companies working on psychedelic drugs included Mind Medicine (MNMD), Cybin (CYBN), Compass Pathways (CMPS) and Atai Life Sciences (ATAI).