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Epilepsy is a common neurological disease. Anti-seizure medication (ASM) is the first-line treatment, beginning with monotherapy and, in uncontrolled epilepsy, progressing to combination therapy over time, with the goal of seizure freedom. Cenobamate is an oral ASM approved for the treatment of focal (partial-onset) seizures in adults. Two clinical studies (C013, C017) evaluated adjunctive cenobamate in uncontrolled focal epilepsy despite treatment with one to three ASMs. In C013, cenobamate 200 mg/day, and in C017, cenobamate 100, 200, and 400 mg/day reduced seizure frequency by 55.6%, 35.5%, 55.0%, and 55.0%, respectively. Up to 20% more cenobamate-treated (C013: 200 mg/day, C017: 400 mg/day) patients achieved zero seizures versus placebo during the maintenance phase of therapy. Three cases of drug reaction with eosinophilia and systemic symptoms, including one fatality, were reported during clinical development with starting doses ≥50 mg/day and weekly up-titration. Safety data from C013, C017, and an open-label safety study (C021), demonstrated the most common adverse events associated with cenobamate were central nervous system-related. Given the efficacy and seizure-free rates, along with the side effect profile confirmed in C021 with a lower initial dose and slower up-titration every 2 weeks, cenobamate is a potentially important addition to currently available ASMs.

Cenobamate for the Treatment of Focal Seizures