SK Life Science XCOPRI CV Receives FDA Approval

SK Life Science, a subsidiary of SK Biopharmaceuticals, have announced that the U.S. Food and Drug Administration (FDA) approved two new administration options of XCOPRI (cenobamate tablets) CV, an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.

“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 healthcare providers managing their care.”

The FDA-approved label update considered the results of an open-label, randomised, single-centre, 3- period, 6-sequence, balanced crossover study demonstrating bioequivalence between three administration routes including swallowing an intact tablet, as a crushed tablet suspended in water and taken orally, and as a crushed tablet suspended in water and administered via a nasogastric tube.


Posted

in

by

Tags:

Comments

Leave a Reply

Your email address will not be published. Required fields are marked *