SK Biopharmaceuticals announced on the 1st that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an oral suspension formulation of cenobamate, its innovative anti-seizure medication for epilepsy, marketed in the United States under the brand name XCOPRI.

The company stated that this application seeks approval for an additional formulation following the existing tablet formulation and targets adult patients with partial-onset seizures (POS).

SK Biopharmaceuticals explained that an oral suspension is a formulation taken by dissolving the drug in liquid, which can improve administration convenience for patients who have difficulty swallowing tablets. The company added that, depending on the patient’s condition or treatment setting, the new formulation is expected to allow more flexible dosing.

Previously, at the 2025 American Epilepsy Society (AES) Annual Meeting held last year, the results of a pharmacokinetic (PK) study comparing the two formulations were presented in a poster session. According to the study, the tablet and oral suspension showed generally similar absorption and drug exposure profiles in the body, confirming that they can provide pharmacokinetically equivalent effects.

SK Biopharmaceuticals stated that it is concurrently conducting clinical development of cenobamate in pediatric patients. Based on the NDA for adults and the results of pediatric clinical trials, the company plans to sequentially expand the indicated age group to include pediatric and adolescent patient populations.

Lee Dong-hoon, CEO of SK Biopharmaceuticals, said, “The cenobamate oral suspension formulation is the result of reflecting the treatment environment of patients who have difficulty taking tablets,” adding, “Going forward, the company will continue to expand treatment options from a patient-centered perspective and address the unmet medical needs of diverse patient groups to broaden the prescription base.”

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