Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg) |
| Drug Class | Positive allosteric modulators of the γ-aminobutyric acid (GABAA) ion channel |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of partial-onset seizures in adult patients.
Summary
- Cenobamate (Xcopri) is indicated for the treatment of partial-onset seizures in adult patients and has shown higher responder rates (>50% seizure reduction) compared to several third-generation antiseizure medications like brivaracetam, perampanel, lacosamide, and eslicarbazepine acetate.
- The information was derived from 10 systematic reviews/meta-analyses that focused on the efficacy, safety, and medical cost impact of cenobamate compared to other antiseizure medications in managing partial-onset seizures.
- In terms of specific seizure types control such as focal to bilateral tonic-clonic seizures, which are associated with a significant risk for Sudden Unexpected Death in Epilepsy (SUDEP), cenobamate has demonstrated promising results. However, more studies focusing on different subpopulations and seizure types, including nocturnal ones, are needed.
- Safety analysis shows that adverse events leading to discontinuation were comparable between cenobamate and other antiseizure medications. Common side effects include fatigue, vertigo, dizziness, somnolence, headache, and nausea, which align with those experienced with other antiseizure medications.
- Updated analyses suggest that unlike many older antiseizure medications carrying FDA-mandated class label warnings based on older data about increased suicidality risk, this does not significantly apply to cenobamate, thus making it safer, comparatively speaking.
- While providing high therapeutic impact combined with lower direct medical costs than third-generation antiseizure medications, especially within Spain's healthcare context, the efficacy should be balanced against tolerability when titrating dose due to its potential drug-drug interactions, particularly with sensitive substrate drugs, along with higher dropout rates at doses, for example, 400 mg due to adverse effects.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xcopri (cenobamate) Prescribing Information. | 2024 | SK Life Science Inc., Paramus, NJ |