Peer-reviewed medical journals and Lykos Therapeutics press releases

FDA Rejects MDMA for PTSD Treatment, Requests More Research

Aug 9, 2024, 09:21 PM

The U.S. Food and Drug Administration (FDA) has rejected the application for the use of MDMA-assisted therapy to treat PTSD. The decision marks a setback for the psychedelic space, as the agency has requested an additional Phase 3 study to further investigate the safety and effectiveness of MDMA. Lykos Therapeutics, the company behind the application, will need to conduct further research to address the FDA's concerns.