The FDA Approves Active Ingredient Derived from Marijuana to Treat Epilepsy

On June 25th, 2018, the U.S. Food and Drug Administration (FDA) approved the drug, Epidiolex, for the treatment of seizures associated with two rare forms of epilepsy, Dravet syndrome, and Lennox-Gastaut syndrome[1]. The active ingredient in Epidiolex, cannabidiol (CBD), is a chemical compound found in marijuana, but is not associated with the euphoria caused by tetrahydrocannabinol (THC)[2]. Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from marijuana.

Epidiolex was tested in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome[3]. The FDA approved Epidiolex under Priority Review granted for Dravet syndrome, and Orphan Drug designation was granted for both Dravet syndrome and Lennox-Gastaut syndrome indications[4]. Clinical and nonclinical studies were also conducted to assess the potential abuse of Epidiolex because CBD is currently a Schedule

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