FDA Declines Application For MDMA PTSD Therapy, Pulls Study On Psychedelic Buyers

FDA will not approve Lykos Therapeutics’ application for midomafetamine (MDMA)-assisted psychotherapy to treat post-traumatic stress disorder (PTSD), the company announced late Friday (Aug. 9), and will require Lykos to conduct another Phase 3 trial before reconsidering the application, a process that could take years, despite a push from lawmakers and advocates to make the treatment available for veterans and other PTSD patients.