SK Life Science, a US pharmaceutical company specializing in treatments for central nervous system disorders, has announced the US Food and Drug Administration (FDA) approval of two new administration options for XCOPRI® (cenobamate tablets) CV, an antiseizure medication. This development marks a key milestone in enhancing treatment accessibility for adults with partial-onset seizures.

The newly approved administration options allow XCOPRI tablets to be crushed and mixed with water, providing patients with additional flexibility in medication administration. Patients can now take XCOPRI either as an oral suspension or through a nasogastric tube, addressing the needs of individuals who may have difficulty swallowing tablets whole.

Louis Ferrari, BS, RPh, MBA, Vice President of Medical Affairs at SK Life Science, emphasized the significance of this approval in meeting the diverse needs of patients living with epilepsy. "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," Ferrari stated. 

"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," Ferrari added.

The FDA's decision to approve these new administration options was informed by the results of a comprehensive study demonstrating bioequivalence between three administration routes: swallowing an intact tablet, taking a crushed tablet suspended in water orally, and administering a crushed tablet suspended in water via a nasogastric tube. The study's findings highlighted the efficacy and safety of XCOPRI across different administration methods.