Opinion: Turning a ‘no’ vote into progress: How to advance MDMA-assisted psychotherapy for PTSD
Many people have interpreted as a setback the “no” vote by an advisory committee to the Food and Drug Administration on Lykos Therapeutics’ new drug application for MDMA-assisted psychotherapy for post-traumatic stress disorder. We believe it is an opportunity to build upon Lykos’ success and rally support for better-funded, well-controlled clinical trials to determine the safety and efficacy of a promising PTSD treatment.
Upon reviewing the FDA’s and Lykos’ briefing documents, the Psychopharmacologic Drugs Advisory Committee deemed the study data insufficient to approve the application, and it determined that the company’s risk evaluation and mitigation strategy did not fully address potential harms of this therapy.
