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.
Yang YT, Szaflarski JP. The US Food and Drug Administration’s Authorization of the First Cannabis-Derived Pharmaceutical: Are We Out of the Haze? JAMA Neurol. 2019;76(2):135–136. doi:10.1001/jamaneurol.2018.3550
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