Summary

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• Xcopri (cenobamate) is indicated for the treatment of partial-onset seizures in adult patients.
• This summary is based on the review of 10 systematic review(s)/meta-analysis(es). ^[1-10]
• Seizure Reduction: Cenobamate achieved a 50% seizure reduction in 50.1% of patients in RCTs compared to 23.5% with placebo (RR 2.18, 95% CI 1.67-2.85, p<0.001). In real-world settings, 68% of patients experienced a >50% seizure reduction.
• Seizure Freedom: Cenobamate led to seizure freedom in 14.9% of patients versus 4.5% for placebo (RR 5.32, 95% CI 2.94-9.62, p<0.001). A meta-analysis reported seizure freedom rates at 16.2% [8.38; 28.97].
• Comparison with Other ASMs: Cenobamate outperformed third-generation ASMs in achieving ≥50% seizure reduction, with higher rates observed against brivaracetam (OR 2.02), eslicarbazepine (OR 1.93), lacosamide (OR 1.86), and perampanel (OR 2.07). SUCRA analysis favored cenobamate for both ≥50% and 100% seizure reduction.
• Specific Seizure Types: Cenobamate demonstrated efficacy in reducing focal to bilateral tonic-clonic seizures (FBTCS) with an efficacy range of 18-59% above placebo.
• Adverse Events (AEs): Cenobamate was associated with AEs in 76.9% of patients compared to 66.8% for placebo (RR 1.14, 95% CI 1.02-1.26, p=0.021). Common AEs included dizziness, somnolence, fatigue, headache, and nausea. Higher dropout rates were observed at higher doses (400 mg) due to AEs (RR 2.09, 95% CI 1.17-3.71, p=0.012).
• Serious AEs: There was no significant increase in serious AEs with cenobamate (RR 1.48, 95% CI 0.93-2.33, p=0.1).
• Suicidality: No evidence indicated an increased risk of suicidal ideation or attempts compared to placebo.
• Population Types and Subgroup Considerations: Cenobamate was primarily studied in adults with drug-resistant epilepsy (DRE) and uncontrolled focal seizures, showing consistent efficacy in real-world settings similar to RCTs. There were no significant differences in outcomes based on age or gender, and while efficacy in reducing focal to bilateral tonic-clonic seizures (FBTCS) was noted, data specific to nocturnal FBTCS were not reported.