SK Biopharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an oral suspension formulation of Cenobamate, their leading epilepsy medication.
This application seeks approval for a liquid formulation of Cenobamate as an alternative to the existing tablet form, specifically targeting adult patients experiencing partial-onset seizures.
The development of this oral suspension aims to provide a more convenient option for patients who struggle with swallowing tablets. It offers flexible dosing and administration tailored to individual patient needs.
Data presented at the 2025 American Epilepsy Society Annual Meeting demonstrated pharmacokinetic equivalence between the tablet and oral suspension formulations of Cenobamate, indicating similar drug absorption and exposure rates for both.
“The Cenobamate oral suspension formulation reflects our commitment to addressing the diverse treatment needs of patients, particularly those who cannot easily take tablets,” stated Lee Dong-hoon, President of SK Biopharmaceuticals.
“We are dedicated to expanding treatment options with a patient-centric approach and broadening our prescription base by fulfilling unmet medical needs across various patient populations.”
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