FDA Denies Approval of MDMA-Assisted Therapy for PTSD.
The American journal of nursing – November 01, 2024
Source: PubMed
Summary
Despite promising Phase 3 trials, regulators declined to approve MDMA-assisted psychotherapy for PTSD treatment, citing safety concerns and methodological issues in clinical studies. The decision impacts thousands of veterans and trauma survivors who showed significant symptom improvement in controlled therapeutic settings. Officials requested additional safety data and stricter protocols before reconsideration.
Abstract
The agency cited potential dangers and flaws in research methodology.