Health Canada Approves Jazz Pharmaceuticals’ Epidiolex

NEW YORK- Canada’s federal health regulator, Health Canada, has recently approved Epidiolex, a cannabinoid-based medicine developed by Jazz Pharmaceuticals Canada. This approval positions Epidiolex as a supplementary therapy for certain rare and severe forms of epilepsy, marking a significant milestone in the treatment of these conditions.

Epidiolex, already the world’s top-selling clinically proven cannabinoid-based medicine, reported global sales of approximately $604.8 million (or 823 million Canadian dollars) in the first nine months of Jazz’s fiscal year. This figure notably surpasses the total sales of Canada’s entire medical cannabis industry in 2022, which amounted to CA$410 million, a decrease of 7.4% from the previous year according to Statistics Canada.

Canada Joins a Growing List of Approving Countries

With this approval, Canada becomes the 36th country to authorize Epidiolex, joining others like the United States, the European Union, and South Korea. The medication, administered as an oral solution, is produced by the United Kingdom-based GW Pharma, acquired by Jazz Pharmaceuticals in a significant $7.2 billion deal in 2021 – the largest M&A deal in the cannabis industry to date.

Clinical Trials and Health Canada’s Endorsement

The approval of Epidiolex by Health Canada was grounded in the results from five double-blind, randomized, placebo-controlled Phase 3 clinical trials. Paul Petrelli, general manager of Jazz Pharmaceuticals Canada, emphasized the importance of this approval for individuals suffering from specific rare epilepsies and their families, noting it as a new treatment option for conditions like Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC).

A New Chapter in Cannabinoid-Based Medicines

Epidiolex’s approval marks a distinct shift in the perception and utilization of cannabinoid-based medicines in Canada. Only a few such medicines, including Sativex (approved in 2005 and marketed by Bayer Canada), have been authorized for sale by Health Canada and listed in the Drug Product Database. Unlike unapproved medical cannabis treatments, Epidiolex underwent successful clinical trials, earning it a Drug Identification Number (DIN), a testament to its clinically proven medical outcomes.

Declining Sales of Unapproved Medical Cannabis

Concurrently, sales of federally regulated but medically unapproved cannabis products have been on a decline. The first half of the 2023 calendar year saw spending on medical cannabis drop to CA$185 million, the lowest since 2016. This trend is attributed to Canada’s prohibition of unapproved medical cannabis sales in pharmacies and the legalization of recreational marijuana in 2018, which has shifted patients towards the 3,500 adult-use stores across the country.

Despite this, Canada maintains its position as the world’s largest federally regulated market for unapproved medical cannabis, closely followed by Australia, which doesn’t track legal, unapproved sales of medical cannabis.

The approval of Epidiolex in Canada not only underscores the potential of cannabinoid-based medicines in treating complex medical conditions but also reflects a growing acknowledgment of their therapeutic value. This development signifies a crucial step forward in integrating cannabinoid-based treatments into mainstream medical practices, offering new hope for patients with rare and severe forms of epilepsy.