MDMA Rejection Raises New Questions on Psychedelic Drug Clinical Trials
The U.S. Food and Drug Administration (FDA) recently rejected an application to approve the use of MDMA as a treatment for post-traumatic stress disorder (PTSD). The MDMA formulation, developed by Lykos Therapeutics, would have been administered in combination with psychotherapy if it had been approved. In its rejection, the federal agency requested for more clinical trials to be done to gather additional data on the drug’s effectiveness and safety. This decision comes just months after the FDA’s advisory committee determined that the application made by Lykos was lacking on both fronts. The decision is a significant change in the drug’s…






