SK Biopharmaceuticals announced that it submitted a new drug application to the US Food and Drug Administration for the oral suspension formulation of its epilepsy drug Cenobamate.
In addition to the existing tablet form, this NDA seeks approval for a liquid option for adult patients with partial-onset seizures.
The liquid-form oral suspension aims to enhance convenience for patients who have difficulty swallowing tablets, offering flexible administration based on patient needs.
According to research unveiled at the 2025 American Epilepsy Society’s Annual Meeting, the tablet formulation and oral suspension formulation both demonstrated similar drug absorption and exposure rates, proving their pharmacokinetic equivalency.
“The oral suspension formulation of Cenobamate reflects the treatment environment of patients unable to take tablet forms,” said Lee Dong-hoon, president of SK Biopharmaceuticals.
“Moving forward, we plan to expand treatment options with a patient-focused approach, and broaden our prescription base by addressing unmet medical needs among various patient groups.”
By Lee Han-gyoul (stlee0329@heraldcorp.com)
