pharm edaily

[Kim Jinsoo, Edaily Reporter] SK Biopharmaceuticals announced Sunday that its U.S. subsidiary, SK Life Science, is presenting key findings on cenobamate (marketed in the U.S. as Xcopri) at the 77th Annual Meeting of the American Academy of Neurology (AAN), held April 5 in San Diego, California.

(AAN Home page)

The presentations include both clinical trial results and real-world data (RWD) supporting cenobamate’s role in reducing seizures and optimizing epilepsy management.

The study involved a retrospective, multicenter analysis conducted in the United States with 37 adult patients (age 18 and older) with focal seizures. Patients had been taking cenobamate at a dose of 50 mg/day or higher as adjunctive therapy for at least two weeks. The researchers analyzed responsive neurostimulation (RNS) data from these patients.

The study met its primary endpoint, showing a statistically significant reduction in epileptiform activity during the 12-week treatment period compared with the 8-week baseline. The frequency of epileptiform activity declined by approximately 84 percent, from a baseline average of 15.7 events per 28 days to 2.5 events per 29 days at the final assessment.

The most commonly reported adverse events were dizziness and drowsiness. However, these effects were mitigated by gradual dose escalation of cenobamate or dose reduction of concomitant antiseizure medications (ASMs).

“Seizure freedom remains a critical treatment goal for many people with epilepsy, though it is difficult to achieve,” said Louis Ferrari, vice president of medical affairs at SK Life Science. “This study is meaningful in that it evaluates the effectiveness of cenobamate and other adjunctive ASMs using RNS data as an objective measure.”

SK Life Science is also presenting a total of six poster presentations at the conference, offering a comprehensive analysis of cenobamate’s efficacy, safety and therapeutic potential. The company aims to demonstrate the broad applicability of the treatment across diverse patient populations and to support future therapeutic strategies.