The first cannabis-based drug that treats two type of epileptic syndromes is now available in the United States as of November 1st in all 50 states.
GW Pharmaceutical’s Epidiolex was approved over the summer by the Food and Drug Administration to treat Dravet syndrome and Lennox-Gastaut syndrome. It was then in September that the US Department of Justice and the Drug Enforcement Administration classified Epidiolex as a Schedule V substance so that the drug could be legally prescribed by doctors in the United States.
“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,” remarked Justin Gover, CEO of GW Pharmaceuticals.
He added, “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.
Dr. Orrin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone Health, who also served as the lead investigator of two of three phase three clinical trials of the drug said, “In those syndromes, when [Epidiolex] was added to three other seizure [medications], on average, it reduced convulsive seizures — or ‘drop seizures’ — by about 25% to 28% compared to a placebo,” Devinsky said. “So I think it’s very important to recognize … that it clearly is effective, and this was statistically significant in all three of the large studies that we did, but by the same token, the effect was modest.
“There are some people who had dramatic improvements. Many had a modest improvement, and some had no improvement. So it’s not a miracle drug. It’s an effective drug, and I think its side effect profile is quite good compared to other seizure drugs that we have, but it’s not a miracle cure,” he added.
GW Pharmaceuticals has said that 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. According to the company, “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).”