SK Biopharmaceuticals, Co., Ltd. says Health Canada has accepted Paladin Labs Inc.’s filing of a new drug submission (NDS) for cenobamate as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
If Health Canada approves the NDS, Paladin Labs would be able to launch cenobamate in Canada.
In December 2021, SK Biopharmaceuticals entered into definitive agreements with Endo International plc’s subsidiary, Endo Ventures Limited, to commercialize cenobamate in Canada. Under the agreements, Paladin Labs, a Canada-based operating company of Endo, is responsible for all commercial activities. SK Biopharmaceuticals will receive milestone payments for future approval and commercialization, as well as additional supply benefits as a result of these agreements.
Dexcel Pharma, an Israeli partner of SK Biopharmaceuticals, has also completed submission of its new drug application for cenobamate, and has received filing acceptance from the Israel Ministry of Health.
Cenobamate is an anti-seizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK life science.
While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.
Cenobamate is approved in the U.S. for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI(cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone.
Cenobamate is also approved in the European Union and the U.K. for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY.
Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and in the Greater China region, respectively.