The FDA approved the first cannabis-based medication for epilepsy earlier in the year. The drug, Epidiolex, is an oral solution used to treat certain types of epilepsy and is now available in 50 states across the US. The medication has been approved for use in patients over the age of two, for the treatment of Dravet syndrome and Lennox Gastaut syndrome. The first is a rare genetic dysfunction which usually begins in the first year of life. The second is a type of epilepsy which mostly starts between ages 3 and 5.
In April this year, it was recommended by an advisory committee that Epidiolex should be approved by the FDA. The agency went on to approve the drug in June, and in September, it was classified as a Schedule V Substance. This means that it can be legally prescribed by doctors in the US, whilst CBD and medical marijuana remain under the category of Schedule 1 substances.
FDA Commissioner Dr. Scott Gottlieb said in a written statement: “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.”
According to GW Pharmaceuticals, who manufacture the drug, some of the most common side effects of Epidiolex include fatigue, drowsiness, loss of appetite, diarrhea, and an increase in liver enzymes. Some pharmacists have commented on its approval, describing the drug as working between “fairly” and “very well”. Pharmacist Shauna Garris, who is an assistant professor at the University of North Carolina’s Eshelman School of Pharmacy, said that the recent FDA approval shows a “validation of the science of cannabinoid medication.”
GW Pharmaceuticals has confirmed that the average price of Epidiolex will stand at around $32,500 a year. Although it’s unclear at this stage, they expect that it will be covered by most health insurance plans, adding that: “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).”
In addition to this, they will be launching a support program for patients. From this, they plan to “help patients who have been prescribed Epidiolex gain access to therapy. The program offers patient/caregiver-focused education and resources to help lower out-of-pocket costs or provide product at no cost for eligible patients.”
In a statement, Justin Gover, CEO of GW Pharmaceuticals, the maker of Epidiolex, noted: “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. 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.”