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), the Dravet syndrome or tuberous sclerosis complex (TSC) – in patients aged 2 years and older.
These three pathologies are rare and severe forms of epilepsy that cause multiple types of seizures, generally resistant to treatment.
CBD for epilepsy
“Living with LGS, Dravet syndrome or CTS is very difficult. This means having to endure recurring attacks every day. It is a difficult and isolating experience for people living with these conditions, and it is 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 equitable and rapid access to promising treatment options.”
Epidiolex is a cannabis-based medicine that contains only cannabidiol. It is available with a prescription and administered as an oral solution, like a regular CBD oil.
“Although there are many anticonvulsant medications for different epilepsies, the rare and severe forms of childhood epilepsies such as LGS, Dravet syndrome and CTS have only limited approved therapies and are often resistant to treatment. This makes these diseases extremely difficult to treat,” explained 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 with a total of 939 patients with LGS, Dravet syndrome or CTS.
Following approval from Health Canada, Jazz will work to ensure reimbursement for eligible patients.
In addition to Canada, Jazz has obtained approval of Epidiolex cannabidiol oral solution, known here as Epidyolex, for these 3 forms of epilepsy, in 36 other countries, including the United States, the Union European Union, Great Britain, Australia, New Zealand, Israel and Switzerland.
