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. 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). 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. 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. Clinical and nonclinical studies were also conducted to assess the potential abuse of Epidiolex because CBD is currently a Schedule