Jazz Pharmaceuticals has received approval from Health Canada for Epidiolex, a cannabis-derived seizure therapy. Epidiolex, a plant-based oral cannabidiol solution, is now approved as an adjunct therapy for seizures associated with three rare forms of epilepsy—Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC)—in patients aged two years and older. Originally developed by GW Pharmaceuticals, Epidiolex became part of Jazz's portfolio following GW's acquisition in 2021.
The approval is significant for patients facing epileptic encephalopathy, as LGS and Dravet syndrome are types of this condition characterized by seizures. LGS requires management with multiple seizure medications, while Dravet syndrome is known for its treatment-resistant nature. Tuberous sclerosis complex (TSC), a rare genetic condition causing benign tumors in various body parts, including the brain and spinal cord, is often associated with epilepsy.
Health Canada's approval, announced in a November 23 press release, is grounded in the positive outcomes of five Phase III clinical trials. These trials, conducted across different age groups, successfully met their primary endpoints. Commonly observed side effects of Epidiolex include diarrhea and vomiting. It's important to note that caution is advised for the use of Epidiolex in geriatric patients, as this patient group has not been studied in cannabis clinical trials.