PARAMUS, N.J., June 15, 2026
SK Life Science, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for an investigational oral suspension formulation of cenobamate for the treatment of focal seizures in adults. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2027, marking a significant regulatory milestone for the company’s efforts to expand treatment options for people living with epilepsy. The investigational formulation is designed to provide an alternative administration option for patients who experience difficulty swallowing tablets, addressing an important real-world challenge in epilepsy care. The NDA acceptance further reinforces SK Life Science’s commitment to delivering patient-centered innovations that improve treatment accessibility and support individualized disease management strategies.
Alternative Formulation Aims to Address Unmet Needs in Epilepsy Care
The investigational oral suspension formulation of cenobamate, the active ingredient currently marketed in tablet form for focal seizures in adults, has been developed specifically for patients who may struggle with tablet administration. Difficulty swallowing medication remains a significant barrier for many individuals living with chronic neurological disorders, potentially impacting adherence and treatment outcomes. By introducing a liquid formulation, SK Life Science aims to expand access to therapy and provide greater flexibility for healthcare providers and patients.
Company executives emphasized that the NDA acceptance reflects a broader strategy focused on delivering treatment options that align with the diverse needs of epilepsy patients and caregivers. The oral suspension formulation is intended to complement existing cenobamate tablet therapy rather than replace it, offering an additional administration choice that could improve convenience and support long-term disease management.
Cenobamate Continues to Strengthen Its Role in Seizure Management
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Cenobamate tablets are already approved in the United States for the treatment of focal seizures in adults and have established an important role within the epilepsy treatment landscape. The antiseizure medication is recognized for its unique dual mechanism of action, which includes preferential inhibition of persistent sodium currents and enhancement of GABA-A receptor-mediated inhibitory signaling, helping reduce abnormal neuronal excitability associated with seizures. The NDA submission for the oral suspension formulation includes data supporting the product’s safety, tolerability and pharmacokinetic profile, providing the foundation for FDA review.
The regulatory filing reflects ongoing efforts to maximize the therapeutic potential of cenobamate while extending its benefits to a broader patient population. If approved, the new formulation could further strengthen the product’s position as a flexible treatment option for adults with focal seizures who require alternative methods of administration.
Expanding Innovation in a Large and Underserved Patient Population
Epilepsy remains one of the most common neurological disorders worldwide and continues to present substantial clinical challenges despite advances in treatment. Approximately 3.4 million people in the United States are living with epilepsy, while nearly 150,000 new cases are diagnosed annually. Importantly, almost 40% of patients fail to achieve seizure freedom despite currently available therapies, highlighting the ongoing need for innovation and individualized treatment approaches. Beyond seizure control, epilepsy can significantly affect quality of life, daily functioning, independence and patient safety.
SK Life Science believes that advancing additional formulations of proven therapies represents an important step toward addressing these unmet needs. As the FDA begins its review process ahead of the January 2027 PDUFA date, the company remains focused on expanding therapeutic options for epilepsy patients and supporting more personalized approaches to seizure management. The acceptance of the NDA for cenobamate oral suspension underscores the growing importance of patient-centric drug development and may ultimately provide a valuable new treatment alternative for adults living with focal seizures.
Source: SK Life Science press release
