The daily administration of a proprietary CBD extract (Epidiolex) is safe and effective in the treatment of Lennox-Gastaut syndrome, a severe form of pediatric epilepsy, according to clinical data published in The New England Journal of Medicine.
An international team of researchers assessed the adjunctive daily administration of either 10mg or 20mg of CBD versus placebo over a period of 14 weeks in 225 patients with the disease. Subjects taking the higher dosage experienced a 42 percent reduction in seizure frequency; those taking the lower dosage experienced a 37 percent reduction, but also reported experiencing fewer side effects. The most commonly reported adverse events were somnolence, decreased appetite, and diarrhea.
The findings are similar to those of prior randomized studies evaluating the use of Epidiolex in patients with intractable forms of epilepsy.
Regulators at the US Food and Drug Administration are expected to grant market approval this summer to Epidiolex for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. If approved, it will be the first non-synthetic cannabinoid available by prescription in the United States.