SK Biopharmaceuticals said April 1 it has submitted a new drug application to the U.S. Food and Drug Administration for an oral suspension formulation of its epilepsy drug cenobamate.
The filing seeks approval of an additional formulation following the existing tablet version, for adults with partial-onset seizures. The company said the liquid oral suspension is expected to improve convenience for patients who have difficulty swallowing tablets and allow more flexible dosing depending on a patient’s condition and treatment setting.
SK Biopharmaceuticals said it has been expanding the drug’s use in clinical practice and is also conducting pediatric clinical development of cenobamate.
Based on the adult NDA and pediatric trial results, the company said it plans to gradually expand the eligible age group to include pediatric and adolescent patients.
At the 2025 annual meeting of the American Epilepsy Society, the company presented poster data from a pharmacokinetic study comparing the tablet and oral suspension formulations. The two formulations showed generally similar absorption and drug exposure, indicating pharmacokinetic equivalence.
Lee Dong-hoon, CEO of SK Biopharmaceuticals, said the oral suspension reflects the treatment needs of patients who struggle to take tablets. He said the company will continue to broaden patient-centered treatment options and address unmet medical needs across different patient groups to expand its prescribing base.
* This article has been translated by AI.
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