FDA advisory committee rejects MDMA application for PTSD, but…

Summary

The Food and Drug Administration voted 9 to 2 to reject a commercial application for MDMA (midomafetamine) as a treatment for post-traumatic stress disorder. The decision was made by the FDA's advisory committee, which found insufficient evidence to approve the drug for PTSD. The application was submitted by Lykos Therapeutics, the commercial arm of the Multidisciplinary Association for Psychedelic Studies (MAPS).

Study at a glance

Abstract

Last week, the Food and Drug Administration (FDA) voted 9‐2 to reject the application of Lykos Therapeutics, the newly formed commercial arm of MAPS, for “midomafetamine” (actually MDMA, or methylenedioxymethamphetamine) to treat post‐traumatic stress disorder (PTSD).