FDA’s Rejection of MDMA Therapy Draws Ire of Psychedelics Experts
Last week, the U.S. Food and Drug Administration (FDA) rejected a new drug application for MDMA to be administered as treatment for post-traumatic stress disorder. In its rejection, the federal agency asked the company that filed the application, Lykos Therapeutics, to conduct additional trials to further study the effectiveness and safety of its psychedelic formulation. This would require additional funding as well as a number of years to complete, which doesn’t align with Lykos Therapeutics’ expectations. The FDA’s ruling left many upset, particularly experts and patient advocates involved in the development and research of psychedelic treatments. One neuroscientist at the…