FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

FDA announces regulatory actions to accelerate development and access for treatments for serious mental illness after an executive order. The agency says it will prioritize regulatory support for serotonin-2A agonists and related psychedelic medications. It also highlights a plan including national priority vouchers for companies studying psilocybin for treatment-resistant depression and major depressive disorder, and methylone for PTSD. FDA additionally allows an early phase clinical study of noribogaine hydrochloride to proceed after an IND submission as part of efforts to support research into potential therapies for conditions with limited options, including alcohol use disorder. FDA notes these actions support research and evaluation and do not mean any product is approved or proven safe and effective. FDA says it intends to release final guidance for sponsors on designing clinical trials for serotonin-2A agonists, covering study design and monitoring considerations and reflecting input from public comments.