SK Biopharmaceuticals
A New Jersey-based drugmaker is seeking permission to offer an existing epilepsy medicine to more patients. The request is a step toward broader treatment options, not a new FDA approval.
SK Biopharmaceuticals said November 4 that it submitted an application to expand the use of cenobamate, sold in the United States as XCOPRI, to primary generalized tonic-clonic seizures. A separate application submitted in October seeks to extend its existing focal-onset seizure indication to children.
XCOPRI is currently approved in the United States for partial-onset seizures in adults. SK Life Science, the company’s U.S. subsidiary, is based in Paramus, New Jersey.
What the trial showed
According to the company’s announcement, the Phase 3 study supporting the generalized-seizure application enrolled 169 patients aged 12 and older at 122 sites in 12 countries.
Patients receiving cenobamate had a median 71.9% reduction in primary generalized tonic-clonic seizure frequency from their starting level, compared with a 39.6% reduction in the placebo group. The company reported a statistically significant difference, with a p-value of 0.003.
Those figures describe the median change in seizure frequency. They do not mean 71.9% of patients became seizure-free, and the placebo group’s improvement is part of the comparison. The findings are company-reported; the FDA still has to assess the application.
SK said most reported adverse events were mild to moderate, with no new safety signals observed. That does not mean the medicine is free of serious risks.
Three requests, different purposes
The generalized-seizure application is separate from the October request to include pediatric patients with focal-onset seizures. The company did not give a pediatric age cutoff or FDA decision date in its November 4 announcement.
A third application, submitted in March, seeks approval for an oral suspension formulation. SK said that version could offer an alternative for people who have trouble swallowing tablets and was used in its pediatric trial program. Submission alone does not make that formulation available as an approved product.
For families, the practical distinction is between a promising study and a treatment that has cleared regulatory review for a particular age group, seizure type and formulation. This announcement changes the review pipeline; it does not by itself change XCOPRI’s current approved U.S. indication.
Safety remains part of the decision
The safety information accompanying the release warns of serious allergic reactions, liver problems and changes in the heart’s electrical activity called QT shortening. XCOPRI should not be used by people with familial short QT syndrome. Common side effects include dizziness, sleepiness, headache, double vision and tiredness.
The medicine can interact with other drugs, and doses must be increased slowly under a clinician’s direction. Patients should not stop taking seizure medicine suddenly or change treatment based on a regulatory filing. The company warns that abruptly stopping XCOPRI can lead to seizures that do not stop.
The next meaningful milestone is an FDA decision on the requested uses. Until then, these remain proposed expansions of an existing medicine, not newly approved treatments for children or generalized seizures.
JBizNews Desk | Paramus, New Jersey
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