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XCOPRI ™ (cenobamate tablets) Approved in Canada

2023.06.29
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XCOPRI ™ (cenobamate tablets) Approved in Canada

 

Paladin Labs plans to commercially launch XCOPRI™ in December 2023

 

KOREA, JUNE 29, 2023 – SK Biopharamceuticals announced that its partner Paladin Labs has received approval from Health Canada to market and distribute XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.

 

Paladin Labs, an Endo International plc operating company, is expected to commercially launch XCOPRI™  in Canada in December this year. Paladin Labs is 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 appropriate patients have access to XCOPRI™.

 

SK Biopharmaceuticals entered into a licensing agreement with Endo subsidiary Endo Ventures Limited for Endo to commercialize cenobamate in Canada in 2021. Paladin Labs manages all commercial activities related to XCOPRI™ in the region.

 

XCOPRI™ is an anti-seizure medication discovered and developed by SK Biopharmaceuticals and SK Life Science. It is currently marketed in the U.S. as XCOPRI® and Europe under the brand name ONTOZRY®.

 

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 based on the location of the brain in which the seizure activity starts: generalized seizures and focal seizures. Focal seizures (also called partial-onset seizures) affect ~60% of people with epilepsy. While many people with epilepsy will respond to anti-seizure medication, ~30% of patients continue to experience seizures despite treatment with currently available medication options.

 

About Cenobamate

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 United States 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.  The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.

 

Cenobamate is also approved in the European Union and the United Kingdom 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.

 

About SK Biopharmaceuticals

SK Biopharmaceuticals and its U.S. subsidiary SK Life Science are global pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals is focused on early research in oncology. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng and SK Life Science’s website at www.SKLifeScienceInc.com.

 

About Endo International plc and Paladin Labs

Endo (OTC: ENDPQ) 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. Learn more at www.endo.com or connect with us on LinkedIn.

 

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing, medical and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc. For more information visit www.paladin-labs.com.

 

 

References:

  1. Canadian Epilepsy Alliance. https://www.canadianepilepsyalliance.org/about-epilepsy/. Accessed May 26, 2023.
  2. Public Health Agency of Canada. Epilepsy in Canada. 2021. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/64-03-17-2021-Epilepsy-in-Canada-EN-FINAL.pdf. Accessed April 20, 2023.
  3. Epilepsy Canada. https://www.epilepsy.ca/what-is-epilepsy. Accessed May 26, 2023.

 

 

Media Inquiries

SK Biopharmaceuticals

H. Park, Head of Communications

Hyunkyung Cho, Deputy Global PR Manager

skbp_comm@sk.com

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