On Wednesday, SK Biopharmaceuticals announced its submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an oral suspension formulation of Cenobamate, its innovative epilepsy medication.
This NDA seeks approval for an additional formulation, complementing the existing tablet form, specifically targeting adult patients with partial-onset seizures (POS).
The liquid oral suspension is designed to improve ease of use for patients who have difficulty swallowing tablets and allows for more flexible dosing based on individual patient needs and treatment circumstances.
SK Biopharmaceuticals has been expanding Cenobamate’s clinical applications and is currently conducting pediatric clinical trials.
Building on this adult NDA and ongoing pediatric studies, the company aims to progressively extend Cenobamate’s use to pediatric and adolescent patient populations.
At the 2023 American Epilepsy Society (AES) annual meeting, researchers presented a poster session featuring pharmacokinetic (PK) study results comparing the tablet and oral suspension formulations of Cenobamate.
The study demonstrated comparable absorption and drug exposure profiles between the two formulations, confirming their pharmacokinetic equivalence.
Lee Dong-hoon, Chief Executive Officer (CEO) of SK Biopharmaceuticals, commented that the Cenobamate oral suspension addresses the needs of patients who struggle with tablet intake. It is committed to expanding treatment options from a patient-centric perspective and meeting the diverse needs of various patient groups to broaden the prescription base.