One 6/25/18 the FDA approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age or older. The significance of this approval is that it is the first FDA-approved drug that contains a drug substance derived from marijuana.
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana, however CBD does not cause intoxication or euphoria (the “high”) that comes from THC.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In adition to another important treatment option for Lennonx-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”