Epidiolex, a cannabidiol oral solution, has been approved by Health Canada. This will be used as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients 2 years of age and older, according to a Jazz Pharmaceuticals.
These three conditions are rare and severe forms of epilepsy that cause multiple seizure types, which are generally resistant to treatment.
Epidiolex Crosses Boarders
Jazz Pharmaceuticals also reports that Epidiolex is the first and only prescription, plant-derived, cannabis-based medicine approved by the U.S. Food and Drug Administration. The FDA signed off on the use of Epidiolex for Lennox-Gastaut and Dravet in 2018, and then followed in 2020 with the label expansion to treat TSC.
Now, Canadian patients can reap the benefits of this plant-derived medicine.
“Living with LGS, Dravet syndrome or TSC is very difficult. It means enduring recurring seizures every day. This presents a challenging and isolating experience for individuals living with these conditions to experience and places a great deal of stress on caregivers who witness the seizures,” says Laura Dickson, President of the Canadian Epilepsy Alliance, in a news released. “This approval encourages hope and optimism for this community. The priority now becomes ensuring those living with these conditions have equitable and timely access to promising treatment options.”
The Health Canada approval was based on results from five double-blind, randomized, placebo-controlled Phase 3 clinical trials, with a total of 939 LGS, Dravet syndrome, or TSC patients enrolled, making it one of the largest global clinical trial programs to date in rare refractory epilepsy syndromes, reports Jazz Pharmaceuticals.
Following the Health Canada approval, Jazz states that it will work with the relevant stakeholders in Canada to secure reimbursement for eligible patients.