FDA Advisers Overwhelmingly Oppose Approval of MDMA As a Psychotherapeutic Catalyst
Efforts to make MDMA legally available as a psychotherapeutic catalyst hit a daunting roadblock on Tuesday when an expert panel overwhelmingly voted to recommend that the Food and Drug Administration (FDA) reject a new drug application that Lykos Therapeutics submitted in February. Members of the panel expressed several concerns about two Phase 3 studies of MDMA's safety and effectiveness in treating post-traumatic stress disorder (PTSD), including unblinding of subjects, potential underreporting of adverse events, and allegedly inadequate assessment of MDMA's abuse potential. "We are disappoi...