SK Life Science Seeks FDA Approval for Cenobamate Oral Suspension
The U.S. Food and Drug Administration has accepted for review a New Drug Application for an investigational oral suspension of cenobamate. Designed for adults with focal seizures who struggle to swallow tablets, the new formulation faces a target action date of January 31, 2027, under the Prescription Drug User Fee Act.
The proposed liquid treatment aims to broaden access to therapy for epilepsy patients, addressing a specific unmet need in administration for those unable to use standard tablets. Cenobamate is already approved in the United States for treating focal seizures in adults under the brand name XCOPRI.
SK Life Science, a subsidiary of SK Biopharmaceuticals, submitted the application supported by data detailing the safety, tolerability, and pharmacokinetic profile of the suspension. While the FDA's acceptance initiates the formal review process, the agency has not yet granted approval for the new formulation. CEO Donghoon Lee stated that the development reflects a commitment to individualized care within the epilepsy community, as the company prepares to work alongside regulators ahead of the 2027 deadline.
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