Paladin Labs Inc., a subsidiary of Endo International plc announced today that XCOPRI® (cenobamate tablets) is now available in Canada. XCOPRI is indicated as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
"We are pleased to announce the availability of XCOPRI in Canada," said Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. "As a company dedicated to addressing unmet medical needs, we are committed to supporting the ongoing innovation in epilepsy management."
XCOPRI received favourable recommendations for public reimbursement from the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et en services sociaux (INESSS) in 2023. Paladin Labs continues to work with federal, provincial, and territorial government payers across Canada and their negotiating body, the pan-Canadian Pharmaceutical Alliance, to help appropriate patients gain access to XCOPRI as soon as possible.
About Epilepsy1-3
Epilepsy is a chronic neurological condition affecting ~300,000 Canadians. It is characterized by recurrent, unprovoked seizures. While there are many different types of seizures, they can be grouped into two broad categories – generalized seizures and focal seizures – based on where in the brain the seizure activity starts. Focal seizures (also called partial-onset seizures) affect ~60% of people with epilepsy. While many people with epilepsy respond to anti-seizure medication, ~30% of patients continue to experience seizures, despite treatment with currently available medication options.
About XCOPRI
XCOPRI (cenobamate tablets) is indicated as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. It is taken orally, once daily.4
XCOPRI is an anti-seizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. It is a novel molecule with a dual mechanism of action. In pre-clinical studies, XCOPRI has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a modulator of the γ-aminobutyric acid (GABAA) ion channel.4-6 The efficacy and safety of XCOPRI for the treatment of adults with uncontrolled partial-onset seizures (also known as focal-onset seizures) were assessed in two randomized, placebo-controlled, double-blind clinical trials (C013 and C017).5,6 The long-term safety of cenobamate in this population has been studied in an open-label safety study (C021).7
During Studies C013 and C017, a total of 441 patients were exposed to XCOPRI. In both studies, the primary efficacy endpoint was median percent reduction from baseline in seizure frequency per 28 days. The key secondary endpoint was responder rates, defined as the proportion of patients with 50% or greater reduction in seizure frequency. XCOPRI significantly reduced seizure frequency and demonstrated a significantly higher ≥50% responder rate compared to placebo.
Consult the Product Monograph for complete efficacy and safety information.
Cenobamate is currently marketed in the U.S. as XCOPRI® and in Europe under the trademark ONTOZRY®.
About Endo International plc and Paladin Labs
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.
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