BREAKING: FDA Publishes Lykos Therapeutics' MDMA Complete Response Letter (CRL)

MDMA for PTSD faces an FDA rejection via a Complete Response Letter (CRL) issued to Lykos Therapeutics. FDA says approval was blocked by multiple concerns: uncollected or unreported “positive” adverse events, inspection findings of unreported adverse events at at least two sites that increased concerns about safety data reliability, missing durability evidence for treating PTSD as a chronic disease, and signals of selection bias linked to high rates of prior MDMA use and prescreening failures among participants. The CRL advises Lykos to run a new clinical trial to address durability of effect, minimize potential bias, and characterize MDMA safety more adequately, including guidance for each area and a recommendation to consider an independent third-party data audit of study records and reports for any future resubmission.