This summer the first CBD oil drug was approved by the FDA to treat rare and severe forms of epilepsy in patients over the age of 2.
The drug, Epidiolex, was labeled as a Schedule V drug, legal for sale and use in the U.S by the U.S. Department of Drug Enforcement this September.
Epidiolex is approved for the treatment of two rare and severe forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex contains hemp extract, derived from the cannabis plant, and has been shown to reduce epileptic seizures.
FDA Commissioner Scott Gottlieb, MD stated:
“The FDA is committed to advancing scientific research and drug development programs that properly evaluate the active ingredients contained in marijuana. Adequate and well-controlled clinical studies supported Epidiolex’s approval, so prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products.”
Image: GW Pharmaceuticals
The drug, developed by GW pharmaceuticals grows its own plants in order to extract high-quality CBD with powerful health benefits.
This is the first time that a hemp product has been approved by the FDA and paves the way for future research for other CBD/hemp-extract medicines and products.