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FDA Approves New Indication for Epidiolex

Epidiolex, the only FDA-approved solution containing cannabidiol (CBD), received FDA approval yesterday, July 31, 2020, to treat seizures associated with tuberous sclerosis complex (TSC) in patients one year of age or older. TSC is a rare genetic disease that causes non-cancerous tumors to grow throughout the body, particularly the brain, eyes, heart, lungs, kidneys, and skin. Symptoms often include seizures, development delay, and behavioral problems. Symptom severity can vary widely. Prior to the approval, Epidiolex was only approved to treat seizures associated with two forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

According to a press release from the FDA, "Epidiolex's effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period."

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