#United States #Cenobamate #Paramus #Epilepsy #SK Biopharmaceuticals

SK Biopharmaceuticals Expands Cenobamate Drug Application

SK Biopharmaceuticals has recently made significant strides in the treatment of epilepsy by submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). This application seeks to secure approval for cenobamate, known in the U.S. under the brand name XCOPRI®, specifically for treating primary generalized tonic-clonic (PGTC) seizures. Additionally, the application aims to broaden the existing focal onset seizure (FOS) indication to include pediatric patients.

A Step Forward in Epilepsy Treatment

The CEO of SK Biopharmaceuticals, Donghoon Lee, emphasized the importance of this submission as part of the company's commitment to continuously improve treatment options for individuals affected by epilepsy. He stated, "This submission represents an important step in our continued investment in cenobamate and our efforts to reach more people living with epilepsy." This effort builds upon the established use of cenobamate in treating focal-onset seizures in adults and explores its efficacy in a wider demographic, particularly younger patients who experience varying types of seizures.

Supporting the application, SK Biopharmaceuticals referenced promising results from a global Phase 3 trial that assessed cenobamate’s effectiveness in patients aged 12 years and older with PGTC seizures. The trial, which involved 169 participants across 122 sites in 12 countries, found a statistically significant reduction in seizure frequency among those treated with cenobamate compared to those on a placebo. Specifically, patients reported a median 71.9% reduction in seizure frequency from baseline, marking a substantial improvement in managing this debilitating condition.

Focused on Safety and Innovation

Safety was also a critical focus during the trial, with adverse events primarily reported as mild to moderate, aligning with the previously established safety profile of cenobamate. This consistency in safety findings contributes to the ongoing narrative of cenobamate being a reliable option for those seeking effective epilepsy treatment.

If approved, this new indication would not only broaden the scope of cenobamate’s application beyond focal-onset seizures in adults but would also fill a substantial gap in the treatment options available for younger patients experiencing PGTC seizures. This is pivotal in advancing the standard of care for pediatric epilepsy, where treatment options have historically been limited.

Furthermore, in October 2026, SK Biopharmaceuticals submitted a separate sNDA to the FDA to extend the focal-onset seizure indication to pediatric patients, which is backed by data demonstrating cenobamate's safety in young users. The company is also working on an oral suspension formulation of cenobamate, designed for those who struggle to swallow tablets, particularly useful in clinical pediatric settings.

Commitment to Global Epilepsy Initiatives

Since its launch in the U.S. in 2020, SK Biopharmaceuticals has dedicated resources to the development of cenobamate with the ambition of catering to the needs of a broader range of epilepsy patients. The company’s unwavering commitment includes evaluating cenobamate’s effectiveness across diverse seizure types and age groups, developing new formulations, and increasing availability in various global markets.

SK Life Science, Inc., operating from Paramus, New Jersey, stands as the U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a South Korean biopharmaceutical firm focusing on pioneering treatments. Together they aim to advance drug development targeting central nervous system disorders while exploring oncology applications through innovative methodologies, including radiopharmaceutical therapy and targeted protein degradation.

The overarching goal is to provide healthcare professionals with more options and to significantly improve the quality of life for patients living with epilepsy. More information can be found on SK Life Science’s official site.

As SK Biopharmaceuticals continues to enhance its product offerings with an emphasis on efficacy and safety, the exploration into additional applications for cenobamate signals a hopeful outlook for patients grappling with the complexities of epilepsy.