FDA panel evaluates MDMA therapy for post-traumatic stress disorder
Related media - Recent news What is the framework for approval? In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. Status, the recognition of a drug's therapeutic promise, aims to shorten regulatory times. 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 request 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,…
