FDA Law and the Psychedelic Renaissance
By Edgar J. Asebey & James T. O’Reilly* Update Magazine, Food & Drug Law Institute (Spring 2024) On December 11, 2023, the U.S. Food and Drug Administration (FDA) received the first ever New Drug Application (NDA)[1]for a psychedelic-assisted therapy.[2] The application was filed by the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation (PBC) for MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) and represents the culmination of over a decade of clinical trials by the organization. On February 9, 2024, MAPS-PBC, now known as Lykos Therapeutics, announced that FDA had accepted its NDA, granted the application priority review, and assigned a PDUFA[3]target date of August...
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