Marijuana advocates across the world were thrilled to learn that the U.S. Food and Drug Administration has approved the very first cannabis-based drug.
It’s called Epidiolex and it’s an oral solution for patients two years and older for the treatment of seizures associated with two rare and severe forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome.
GW Pharmaceuticals’ Epidiolex is made of cannabidiol, otherwise called CBD, which is a component of marijuana that doesn’t come with the high effect.
The drug is also the first to be approved by the FDA for the treatment of Dravet syndrome, which is a rare genetic condition that shows up in the first year of a person’s life. It is accompanied by frequent fever-related seizures and later in life other seizures also typically happen.
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” stated FDA Commissioner Scott Gottlieb, M.D.
He added, “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. Because of the adequate and well-controlled clinical studies that supported this approval, 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. 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. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
“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,” remarked Billy Dunn, M.D., who is the director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
He also said, “In addition to another important treatment option for Lennox-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.”