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November 19, 2018

The US Food and Drug Administration’s Authorization of the First Cannabis-Derived Pharmaceutical: Are We Out of the Haze?

Author Affiliations
  • 1Center for Health Policy and Media Engagement, George Washington University School of Nursing, Washington, DC
  • 2Department of Health Policy and Management, George Washington University Milken Institute School of Public Health, Washington, DC
  • 3Department of Neurology, University of Alabama at Birmingham School of Medicine
  • 4University of Alabama at Birmingham Epilepsy Center
JAMA Neurol. 2019;76(2):135-136. doi:10.1001/jamaneurol.2018.3550

On June 25, the US Food and Drug Administration (FDA) approved Epidiolex, the first cannabis-derived treatment, for 2 epilepsy syndromes, Lennox-Gastaut (LGS) and Dravet (DS).1 It contains cannabidiol (CBD). While other drugs containing synthetic versions of tetrahydrocannabinol found in the cannabis plant have been previously approved by the FDA, Epidiolex is the first plant extract that will be available in the United States. This signifies that CBD has an accepted medical use, one of the requirements for moving it to a schedule higher than I under the Controlled Substances Act. The decision has significant implications for patients, regulations, and research.