For the very first time in its 88-year history, the U.S Food and Drug Administration has approved a pharmaceutical drug that contains a purified substance derived directly from cannabis.
The oral solution of cannabidiol – or CBD – is also the first FDA-approved drug for the treatment of patients with Dravet syndrome, a rare form of childhood epilepsy that can affect children as young as two years old.
The FDA approval was granted to GW Pharmaceuticals for its epilepsy drug – Epidiolex after a first-of-its kind study showed that CBD can reduce seizures in children with Dravet syndrome. The results were published in the New England Journal of Medicine.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” said FDA Commissioner Scott Gottlieb, M.D.
“The FDA is committed to this kind of careful scientific research and drug development,” he said.
“Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients,” said Dr. Gottlieb.
Prescribers can have confidence in the drug’s “uniform strength and consistent delivery that support appropriate dosing needed” for complex and serious epilepsy syndromes.
“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.” he said.
Although the FDA said that CBD “does not cause intoxication or euphoria (the high) that comes from THC,” it noted that it still falls under the Controlled Substances Act and is a Schedule I substance “because it is a chemical component of the cannabis plant.”