FDA approves Xcopri for oral suspension, nasogastric tube administration

The FDA approved two new delivery methods of Xcopri for adults with partial-onset seizures, with the drug able to be crushed, mixed with water and administered by mouth as an oral suspension or via a nasogastric tube.

According to a press release from SK Life Science Inc., the label update for Xcopri (cenobamate) stemmed from results of an open-label, randomized, single-center, three-period, six-sequence, balanced crossover study.

Bioequivalence of Xcopri was assessed among three administration routes: swallowing an intact tablet, as a crushed tablet suspended in water and taken orally, and as a crushed tablet suspended in water then administered via nasogastric tube.

Previous research established the drug’s safety and found it reduced seizures by more than 90% in adults with the condition.

"The updated label is very beneficial for patients and their caregivers, especially for patients who are institutionalized or hospitalized with a nasogastric tube who can now continue or start receiving cenobamate when they don’t have the ability to swallow the pills,” Louis Ferrari, BS, RPh, MBA, vice president of medical affairs at SK Life Science, told Healio. “Until now there were no alternative methods to administer cenobamate to this patient population; this label update offers another option for health care providers and patients.”