Xcopri FDA Filing May Expand Treatment Options for People With Generalized and Pediatric Epilepsy
KEY TAKEAWAYS
- Phase 3 evidence in adolescents and adults showed a substantially greater median decline in primary generalized tonic-clonic seizure burden with cenobamate than with placebo.
- The regulatory strategy extends beyond generalized epilepsy, with a separate application seeking pediatric use for focal-onset seizures.
- Safety results from the generalized seizure study aligned with the drug’s established profile, with no newly identified safety signals reported.
SK Biopharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) seeking approval of Xcopri (cenobamate; SK Life Science, Paramus, NJ) for primary generalized tonic-clonic (PGTC) seizures, potentially extending the antiseizure medication beyond its current US indication for focal-onset seizures in adults. The company also submitted a separate sNDA seeking to expand the focal-onset seizure indication to pediatric patients, according to a published statement.
The PGTC application is supported by a global phase 3 trial (NCT03678753) that enrolled 169 individuals aged 12 years and older across 122 sites in 12 countries. Participants receiving Xcopri had a median 71.9% reduction in PGTC seizure frequency from baseline compared with a 39.6% reduction among those receiving placebo (P=.003).
Highlights From the Phase 3 Data
- Xcopri was associated with a 71.9% median reduction in PGTC seizure frequency from baseline.
- The corresponding median reduction with placebo was 39.6%, with a statistically significant between-group difference (P=.003).
- Most reported adverse events were mild to moderate.
- No new safety signals were identified, and findings were consistent with the known safety profile of Xcopri.
SK Biopharmaceuticals separately submitted an sNDA in October 2026 to extend the focal-onset seizure indication to pediatric patients. The company also has an FDA application under review for an oral suspension formulation of Xcopri, which was used in its pediatric clinical development program.
Clinical Implications
If approved, the PGTC indication would make Xcopri available for an additional seizure type and extend its potential use to patients beginning at age 12 years. The pediatric focal-onset seizure application represents a separate effort to broaden the age range for the drug’s established indication.
Source
SK Life Science, Inc. SK Biopharmaceuticals submits supplemental new drug application to U.S. FDA for cenobamate. Published November 4, 2026. Accessed November 10, 2026. https://www.prnewswire.com/news-releases/sk-biopharmaceuticals-submits-supplemental-new-drug-application-to-us-fda-for-cenobamate-302929394.html