SK Biopharm Applies for FDA Approval of Cenobamate Oral Suspension

Expansion of Indications to Pediatric Patients Targeting Adults With Partial-Onset Seizures
Broader Clinical Use Expected Following Pharmacokinetic Equivalence Confirmation

On April 1, SK Biopharm announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral suspension formulation of cenobamate (marketed in the U.S. as Xcopri), a treatment for epilepsy.

SK Biopharm corporate logo image. SK Biopharm

This application seeks to add a liquid formulation in addition to the existing tablet, targeting adult patients with partial-onset seizures. The aim is to improve dosing convenience, especially for patients who have difficulty swallowing tablets, as the oral suspension can be administered to them as well.

The oral suspension formulation allows for easy dose adjustment depending on the patient's condition or treatment environment.

Cenobamate is currently also undergoing clinical trials in pediatric patients. SK Biopharm intends to gradually expand the indicated age range based on the results of these pediatric clinical trials and the current application for adults.

Lee Donghoon, CEO of SK Biopharm, stated, "The oral suspension formulation of cenobamate is the result of reflecting the treatment needs of patients who have difficulty taking tablets."

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