SK BIOPHARMACEUTICALS,


Associated tags: FDA, ASM, Disorder, Mouth, Food, Water, Pharmacist, Seizure, CNS, Tablet, Patient, Epilepsy, Central nervous system, MBA, Pharmaceutical industry

XCOPRI® (cenobamate tablets) CV Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube

Retrieved on: 
Thursday, April 11, 2024
FDA, ASM, Disorder, Mouth, Food, Water, Pharmacist, Seizure, CNS, Tablet, Patient, Epilepsy, Central nervous system, MBA, Pharmaceutical industry

"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.

Key Points: 
  • "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, randomized, single-center, 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.