The U.S. Food and Drug Administration has accepted a new drug application for an oral liquid version of the antiseizure medication cenobamate, offering a potential alternative for adults with focal seizures who struggle to swallow pills. The agency set a target decision date of January 31, 2027, under the Prescription Drug User Fee Act.
The investigational formulation is designed for the roughly one third of epilepsy patients who experience difficulty swallowing tablets, a condition known as dysphagia. Currently, cenobamate is only available in tablet form under the brand name XCOPRI, which is already approved in the United States for treating focal seizures in adults. The new liquid suspension aims to fill a gap in care for those who cannot take solid oral medications due to age, neurological impairment, or other medical conditions.
Epilepsy is the fourth most common neurological condition, affecting millions of Americans. Focal seizures, which originate in one area of the brain, can cause a range of symptoms from unusual sensations to loss of awareness. The CDC and Epilepsy Foundation note that uncontrolled seizures can impact safety, daily functioning, and overall quality of life. The oral suspension would provide a more flexible dosing option, potentially improving adherence and outcomes for patients who have struggled with tablet formulations.
The submission includes data on the safety, tolerability, and pharmacokinetic profile of the liquid form. The FDA’s acceptance means the agency has deemed the application complete enough to begin a formal review, though the product has not yet been approved. SK Life Science, the company behind the drug, will continue to work with regulators during the review process.
If approved, the oral suspension would join a growing toolkit for personalized epilepsy care. With a decision expected by early 2027, patients and clinicians may soon have another option to better manage this challenging condition.