Partial-onset seizure epilepsy is where seizures originate in one area of the brain, causing symptoms such as muscle jerking and altered consciousness. Credit: peterschreiber.media via Shutterstock.

South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. 

Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. 

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. 

The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, says Louis Ferrari, SK Life Sciences vice president of medical affairs. 

“In some patients, crushing tablets offer an additional option for dosing and administration by nasogastric tube. This label update addresses an unmet need for this patient population and offers administration alternatives to the healthcare providers managing their care,” says Ferrari. 

See Also:

Xcopri was first approved by the FDA in November 2019 for partial-onset seizures in adults, followed by a European approval of the drug in 2021 under the name Ontozry. The treatment is commercialised by Angelini Pharma, following the acquisition of Arvelle Therapeutics, who signed an exclusive licensing agreement with SK Biopharmaceuticals worth $430m in February 2019. Angelini acquired Arvelle in a $960m deal in 2021.  

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to GlobalData’s Pharma Intelligence Center, Xcopri/Ontozry is forecast to generate $1.5bn in sales in 2027.  

GlobalData is the parent company of Pharmaceutical Technology. 

Partial-onset seizure epilepsy is a type of epilepsy where seizures originate in one area of the brain. Seizures can cause a variety of symptoms depending on the part of the brain affected such as muscle jerking, sensory disturbances, or altered consciousness.