NEW YORK, NY — The long-term use of Epidiolex is associated with reduced seizure frequency in a subset of patients with pediatric, refractory epilepsy, according to clinical data published in the journal CNS Drugs.
A team of investigators from Columbia University in New York and the University of California, San Francisco assessed the efficacy and tolerability of a proprietary CBD extract (Epidiolex) in 26 children with refractory epilepsy over a period of several years.
Authors reported that a subset of the cohort (seven patients) experienced a sustained >50 percent reduction in motor seizures after four-years of treatment. Three of those seven patients remained seizure-free over the duration of the treatment.
By contrast, 15 patients discontinued their use because of a lack of efficacy. Several patients also reported a decrease in appetite, weight loss, and diarrhea, among other adverse events.
“Cannabidiol imparted a clinically meaningful reduction in seizure frequency to a subset of patients with medically refractory epilepsy that was sustained over a period of 2 to 4 years,” authors concluded.
In June, the US Food and Drug Administration approved Epidiolex for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
In September, the US Drug Enforcement Administration reclassified it from Schedule I to Schedule V — the lowest restriction classification available under federal law.
Full text of the study, “Long-term safety, tolerability, and efficacy of cannabidiol in children with refractory epilepsy: Results from an expanded access program in the US,” appears in CNS Drugs.