FDA panel evaluates MDMA therapy for post-traumatic stress disorder
Related media - Linked media What is the framework for approval? In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. Status, a recognition of a drug’s therapeutic promise, aims to shorten regulatory timelines. The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity, Lykos Therapeutics, to commercialize MDMA if it gained approval. FDA approval. The application presents an unusual challenge for the FDA, which typically does not regulate drug treatments associated with talk therapy, an essential part of Lykos’ regimen for treating post-traumatic stress disorder. On June 4,…
