It was just this past summer that the Food and Drug Administration approved GW Pharmaceuticals’ Epidiolex, the first cannabis-based drug to treat twot ypes of epileptic syndroms: Dravet syndrome and Lennox-Gastaut syndrome.
It was in September that the US Department of Justice and the Drug Enforcement Administration classified Epidiolex as a Schedule V substance which would allow the drug to be legally prescribed by doctors in the United States.
On November 1st, the drug became available by prescription in all 50 states in the U.S.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” said Justin Gover, CEO of GW Pharmaceuticals.
“We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
“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,” wrote FDA Commissioner Dr. Scott Gottlieb.
“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,” he added.
GW Pharmaceuticals says the average list price of Epidiolex is $32,500 a year and that it expects that the drug will be covered by most insurance plans. The company said “this price is in line with other branded, FDA-approved anti-epileptic drugs (AEDs), such as Banzel, and access for eligible patients is expected to be similar to such AEDs for similar indications for LGS (e.g., Onfi and Banzel).”
