Objective: To review the pharmacology, efficacy, and safety of oral cenobamate in the treatment of uncontrolled focal epilepsy.
Data sources: The PubMed database and ClinicalTrials.gov were searched using the following terms: cenobamate, Xcopri, and YKP3089.
Study selection and data extraction: Articles published in English between January 2000 and April 2020 related to pharmacology, safety, and clinical trials were assessed.
Data synthesis: In a phase 2 trial, cenobamate reduced the median percentage change in seizure frequency from baseline by 56% compared with 22% for placebo (P < 0.0001). In another phase 2 trial of multiple cenobamate doses, cenobamate reduced seizure frequency by 36% (P = 0.0071) in the 100-mg group and 55% (P < 0.0001) in both the 200- and 400-mg groups, compared to 24% with placebo. Adverse effects of cenobamate appear to be similar to those of other antiseizure medications and primarily affect the neurological system.
Relevance to patient care and clinical practice: In patients taking antiseizure medications who continue to have focal seizures, cenobamate has efficacy at multiple doses and is generally well tolerated. Cenobamate may be distinguished from other antiseizure medications by high rates of seizure freedom not seen in previous placebo-controlled trials, which has the potential to significantly improve quality of life. However, despite this efficacy, Drug Reaction with Eosinophilia and Systemic Symptoms may remain a significant concern with cenobamate.
Conclusion: As seen in clinical trials, cenobamate as an adjunctive, once-daily treatment represents an efficacious and generally well-tolerated therapy for patients with drug-resistant focal epilepsy.
Keywords: Xcopri; cenobamate; epilepsy; partial epilepsies; seizures.