FDA approves new administration routes for Xcopri

2024-04-12

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FDA approves new administration routes for Xcopri

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来源: Pharmaceutical Technology

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.

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.

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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.

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.

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