FDA Accelerates Development and Access to Psychedelic Mental Health Treatments After Executive Order

Following a presidential executive order, the FDA announced actions to speed development and access to treatments for serious mental illness, including national priority vouchers for psilocybin in treatment-resistant depression and major depressive disorder and for PTSD treated with methylone, approval of an early-phase study of noribogaine hydrochloride for alcohol use disorder (the first U.S. trial of an ibogaine derivative), and imminent final guidance to shape serotonin-2A agonist trials—emphasizing rigorous science and safety, especially for veterans.