Epidiolex approved in Canada for the treatment of certain forms of epilepsy

In a press release, Jazz Pharmaceuticals Canada announced that Health Canada has approved the use of Epidiolex®, a pharmaceutical CBD oil, as a treatment for certain forms of epilepsy - Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) - in patients aged 2 and over.

These three pathologies are rare and severe forms of epilepsy, causing multiple types of seizures that are generally resistant to treatment.

CBD for epilepsy

«Living with LMS, Dravet syndrome or CTS is very difficult. It means enduring recurrent attacks every day. It's a difficult and isolating experience for people living with these conditions, and it's very stressful for caregivers who witness the seizures,» said Laura Dickson, president of the Canadian Epilepsy Alliance.

«This approval gives hope and optimism for this community. The priority now is to ensure that people living with these diseases have fair and rapid access to promising treatment options».

Epidiolex is a cannabis-based medicine which contains only cannabidiol. It is available on prescription and administered as an oral solution, like a classic CBD oil.

«Although there are many anticonvulsant drugs available for different epilepsies, the rare and severe forms of childhood epilepsy that are LMS, Dravet syndrome and CTS have only limited approved therapies and are often resistant to treatment. This makes these diseases extremely difficult to treat,» explains Linda Huh, a pediatric epileptologist at BC Children's Hospital and the University of British Columbia.

«Health Canada's approval of Epidiolex is important news for a patient population with unmet needs, as it provides us with an extensively studied treatment option.»

Health Canada's approval is based on the results of five double-blind, randomized, placebo-controlled Phase 3 clinical trials involving a total of 939 patients with LMS, Dravet syndrome or CTS.

Following Health Canada approval, Jazz will work to ensure reimbursement for eligible patients.

In addition to Canada, Jazz has obtained approval for the cannabidiol oral solution Epidiolex, known here as Epidyolex, for these 3 forms of epilepsy in 36 other countries, including United States, the European Union, Great Britain, Australia, New Zealand, Israel and Switzerland.