SK Biopharmaceuticals (326030.KS) said it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for an oral suspension formulation of cenobamate (U.S. brand name: XCOPRI), its innovative epilepsy treatment.
The NDA seeks approval for an additional formulation beyond the existing tablet form, targeting adult patients with focal (partial-onset) seizures. The liquid oral suspension is expected to improve dosing convenience for patients who have difficulty swallowing tablets and enable more flexible administration depending on the patient's condition or treatment setting.
SK Biopharmaceuticals has been expanding the drug's clinical applications on this basis and is currently conducting pediatric clinical development for cenobamate. The company plans to gradually extend the eligible patient population to children and adolescents based on the adult NDA and results from the ongoing pediatric trials.
At the 2025 American Epilepsy Society (AES) annual meeting held last year, pharmacokinetic (PK) study results comparing the existing tablet formulation with the oral suspension formulation of cenobamate were presented in a poster session. The study showed that the two formulations demonstrated generally similar absorption and drug exposure profiles, establishing pharmacokinetic equivalence.
"The cenobamate oral suspension formulation reflects the treatment needs of patients who have difficulty taking tablets," said Lee Dong-hoon, president of SK Biopharmaceuticals. "We plan to continue expanding treatment options from a patient-centered perspective and broaden our prescribing base by addressing unmet medical needs across diverse patient populations."
