A marijuana-based drug received a unanimous thumbs-up from a panel of experts organized by the Food and Drug Administration. The panel voted 13-0 that the FDA should approve Epidiolex—the drug that utilizes pharmaceutical-grade CBD oil and treats rare forms of epilepsy from London-based GW Pharmaceutical.
It should be noted that the FDA is in no way bound by its expert advisory panels, though they usually follow their official opinions. The FDA is expected to make a decision on formal approval by June 27.
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“In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical (effectiveness) in Lennox-Gastaut syndrome and Dravet syndrome, which are serious, debilitating and life-threatening disorders,” the authors noted.
Epidiolex focuses on treating patients over the age of 2 with one of two particularly rare and serious forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. Both syndromes have onset in early childhood and are characterized by multiple seizure types that are difficult to control under existing drugs on the market. There are currently 6 drugs approved to treat patients with Lennox-Gastaut syndrome specifically, and there none approved for Dravet syndrome. About 30,000 people in the U.S. are estimated to have Lennox-Gastaut syndrome, according to the LGS Foundation.
A study involving children with Dravet’s syndrome saw five percent becoming seizure free while taking Epidiolex. None did so taking the placebo. Meanwhile patients experienced a significant reduction in convulsive procedures (39 percent) when compared to placebo. Another study demonstrated that LGS patients saw a median reduction in monthly seizure of up to 42 percent when using Epidiolex compared to a 17 percent drop for placebo.
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This would be the first drug from GW Pharma to be approved in the U.S. Another cannabidiol-based product developed by the company called Sativex treats multiple sclerosis and has regulatory approval in 30 countries outside the U.S.