Reaction mixed over FDA committee rejection of MDMA therapy for PTSD

The FDA's advisory committee recently voted against approving MDMA-assisted therapy for PTSD, concluding that the evidence does not demonstrate the drug's effectiveness. The decision has drawn mixed reactions from field members and an advocacy organization focused on promoting safe, equitable access to psychedelic therapies for mental health.

Study at a glance

Abstract

A recent decision by the U.S. Food and Drug Administration's (FDA) advisory committee to reject psychedelic treatment and therapy to treat post‐traumatic stress disorder (PTSD), citing that the available evidence of midomafetamine, better known as MDMA, fails to show that the drug is effective, has been met with mixed reaction by a member of the field and an advocacy organization committed to advancing safe and equitable access to psychedelic therapies to improve mental health.