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Endo Pharmaceuticals Granted Approval for XCOPRI™ (cenobamate tablets) in Canada

Friday, June 30, 2023

Endo International plc (OTC: ENDPQ) has made an official announcement regarding the approval of XCOPRI™ (cenobamate tablets) by Health Canada. Paladin Labs Inc., an operating company under Endo, has received regulatory approval for XCOPRI™ as an adjunctive therapy for managing partial-onset seizures in adults with epilepsy who haven't achieved sufficient control with conventional treatments.

"Adults with partial-onset seizures often struggle to effectively manage their condition, even with the availability of numerous anti-seizure medications," stated Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. "At Paladin, we are dedicated to addressing the unmet medical needs of these patients, and we are thrilled to have received approval for XCOPRI™, a significant milestone in the treatment of epilepsy."

Paladin Labs is actively collaborating with the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et en services sociaux (INESSS) to ensure that XCOPRI™ is accessible to the appropriate patients who can benefit from it.

The launch of XCOPRI™ by Paladin Labs is scheduled for December 2023.

Epilepsy is a chronic neurological condition that affects around 300,000 Canadians. It is characterized by recurrent, unprovoked seizures. These seizures can be classified into two main categories: generalized seizures and focal seizures. Focal seizures, also known as partial-onset seizures, are experienced by approximately 60% of individuals with epilepsy. While many people with epilepsy can effectively manage their seizures using anti-seizure medications, approximately 30% of patients continue to experience seizures despite treatment.

XCOPRI™ (cenobamate tablets) is an anti-seizure medication developed by SK Biopharmaceuticals and SK life science. It is indicated as adjunctive therapy for adults with epilepsy who have partial-onset seizures and have not achieved satisfactory seizure control with conventional treatment. The medication is taken orally once a day.

XCOPRI™ is a novel small molecule with a dual mechanism of action. Pre-clinical studies have shown that it can reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It also acts as a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.

The efficacy and safety of XCOPRI™ in the treatment of adults with partial-onset seizures were evaluated in two randomized, placebo-controlled, double-blind clinical trials (C013 and C017). Long-term safety was assessed in an open-label safety study (C021).

XCOPRI™ is currently available in the United States under the brand name XCOPRI® and in Europe as ONTOZRY®.

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