The US Food and Drug Administration (FDA) has approved a plant-based cannabidiol formulation for the adjunct treatment of seizures associated with two severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome, in patients 2 years of age and older. LGS and Dravet syndrome both develop in childhood, and most patients experience multiple seizures per day. The formulation of cannabidiol (Epidiolex, developed by GW Pharmaceuticals) is the first approved medication for the treatment of Dravet syndrome. Epidiolex’s effectiveness was studied in three Phase III clinical trials and an open-label extension trial showed that Epidiolex added to existing anticonvulsant treatment significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome, with mild to moderate adverse effects. The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
>> FDA Press Release
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