Xcopri Treatment for Seizures Receives Approval for 2 New Administration Options

The Food and Drug Administration (FDA) has approved 2 new administration options for Xcopri (cenobamate tablet; SK Life Science, Paramus, NJ), an anti-seizure medication indicated for the treatment of partial-onset seizures in adults. The approval permits Xcopri tablets to be crushed and mixed into water for oral ingestion or administration via nasogastric tube.

The approval of these alternate methods of administration is based on data from an open-label, randomized, single-center, 3-period, 6-sequence, balanced crossover study investigating the relative bioavailability of Xcopri when administered through different methods. The study enrolled 24 healthy participants aged 18 to 50 years, who received either 1 dose of Xcopri as an in-tact tablet, as a crushed tablet in water taken orally, or as a crushed tablet in water taken via nasogastric tube. Analysis of the study results demonstrated bioequivalence regardless of route of administration. According to a statement from SK Life Science, the approval of these alternate administration options will enable individuals with partial-onset seizures who have difficulty swallowing to access treatment with Xcopri.

“The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole,” said Louis Ferrari, BS, RPh, MBA, Vice President of Medical Affairs at SK Life Science. “In some patients, crushing tablets offers 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.”