Health Canada approves Endo’s anti-seizure pills

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapies.

Endo operating company Paladin Labs is developing the small molecule anti-seizure medication for a Canadian launch.

Also known as cenobamate, Xcopri works by reducing repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a reduced occurrence of seizures. It is an oral treatment that is taken once daily.

SK Biopharmaceuticals and SK Life Science first discovered and developed the drug, but they gave Endo the rights to commercialise the drug in Canada in a 2021 licensing agreement. In this deal, SK Biopharmaceuticals received an upfront payment of $20m but remained eligible to receive $21m more from Endo, subject to the achievement of certain development and commercial milestones.

Health Canada accepted the Montreal-headquartered company’s regulatory filings for Xcopri in August 2022. This was based on efficacy data from the Phase II and III studies. Phase III data showed that all patients who took Xcopri saw a decrease in their average drug load with a mean change of 29% (mean drug load = 2.52) and 32% (mean drug load = 2.43) after 12 and 24 months of treatment, respectively. Furthermore, a Phase II open-label extension trial (NCT01866111) found that, after a 12-month period, 13% to 16% of patients achieved seizure freedom. The drug is currently being studied in a Phase III trial (NCT05067634), evaluating its efficacy in children aged two to 17 years.

In a 29 June press release, Paladin Labs’ vice-president and general manager Livio Di Francesco said: “Paladin is dedicated to addressing unmet medical needs, and we are proud to achieve this approval—a milestone in epilepsy treatment.”

The US Food and Drug Administration (FDA) first approved Xcopri in 2019, followed by a European approval of the drug in 2021 under the name Ontozry. Paladin Labs aims to launch Xcopri in Canada in December 2023.