Additional Administration Options Approved for Seizure Medication Xcopri

The Food and Drug Administration (FDA) has approved 2 new administration options for Xcopri^® (cenobamate tablets) for the treatment of adults with partial-onset seizures. 

Xcopri tablets can now either be swallowed whole or be crushed. The crushed tablet can be mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. 

The labeling update is supported by data from an open-label, randomized, single-center, 3-period, 6-sequence, balanced crossover study. Findings showed the plasma Cmax and AUC for Xcopri crushed tablets mixed in water, administered either orally or through a nasogastric tube, were similar to whole tablets.

“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, 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 health care providers managing their care.”

Xcopri is available as 12.5mg-, 25mg-, 50mg-, 100mg-, 150mg-, and 200mg-strength tablets.