FDA accepted SK Life Science’s NDA for an oral suspension of cenobamate in focal seizures, with a PDUFA date of January 31, 2027, potentially expanding treatment options for patients with swallowing difficulties.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
SK Life Science has secured U.S. Food and Drug Administration (FDA) review of a New Drug Application (NDA) for an investigational oral suspension formulation of cenobamate for the treatment of focal seizures in adults, potentially expanding administration options for people living with epilepsy.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2027. The application seeks approval of an oral liquid formulation of cenobamate, which is currently approved in the United States as XCOPRI® tablets for adults with focal seizures.
Addressing an Important Treatment Need
The investigational oral suspension formulation would provide an alternative administration option for patients who have difficulty swallowing tablets, a challenge that can complicate long-term treatment adherence and disease management.
Cenobamate is an antiseizure medication discovered and developed by SK Biopharmaceuticals and SK Life Science. The drug reduces abnormal neuronal activity by modulating voltage-gated sodium channels and enhancing GABA-A receptor-mediated inhibition. Cenobamate is marketed as XCOPRI in the United States and is also available in multiple international markets through regional partnerships and licensing agreements.
NDA Supported by Safety and Pharmacokinetic Data
The NDA includes data supporting the safety, tolerability, and pharmacokinetic profile of the investigational oral suspension formulation. The submission is intended to demonstrate that the liquid formulation can provide an alternative administration option while maintaining the established clinical profile of cenobamate.
Because the application seeks approval for a new formulation rather than a new indication, the FDA review focuses on the formulation’s performance and suitability for patients who may not be able to take tablet-based therapy.
Regulatory Milestone for Cenobamate
FDA acceptance of the application marks a key step in broadening the cenobamate treatment portfolio beyond its currently available tablet formulation.
“FDA acceptance of this NDA reflects our continued commitment to broadening treatment options for people living with epilepsy,” said Donghoon Lee, Chief Executive Officer of SK Life Science. “By advancing a cenobamate oral suspension formulation, we aim to help address unmet need among patients who cannot swallow tablets and further support individualized care across the epilepsy community.”
Sunita Misra, MD, PhD, Chief Medical Officer of SK Life Science, said the review acceptance represents an important milestone as the company advances a patient-centered treatment option that addresses real-world challenges faced by people living with epilepsy and their caregivers.
Epilepsy Burden Remains Significant
Epilepsy is a chronic neurological disorder characterized by recurrent, unprovoked seizures and remains one of the most common neurological conditions in the United States.
Approximately 3.4 million Americans live with epilepsy, and about 150,000 new cases are diagnosed each year. Despite the availability of multiple antiseizure therapies, nearly 40% of patients do not achieve seizure freedom, highlighting the ongoing need for individualized treatment approaches and alternative administration options.
Clinical Path Forward
SK Life Science will continue working with the FDA throughout the review process as the agency evaluates the application ahead of its January 31, 2027 action date.
If approved, the oral suspension would expand the cenobamate franchise beyond tablets and provide a new administration option for adults with focal seizures who have difficulty swallowing oral solid medications. The formulation could help address an important practical barrier to treatment while broadening access to cenobamate therapy across the epilepsy community.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.