FDA Approves Cenobamate for Partial-Onset Seizures

The US Food and Drug Administration (FDA) has approved cenobamate tablets (XCOPRI) for the treatment of partial-onset seizures in adult patients.

The safety and efficacy of the SK Life Science therapy was proven in a pair of randomized, double-blind, placebo-controlled trials assessing 655 adults with partial-onset seizures, with or without secondary generalization.

Patients had had seizures for a mean approximate 24 years, and a median seizure frequency of 8.5 per 28 days during an eight-week baseline period. Investigators assessed doses of 100 mg, 200 mg, and 400 mg daily cenobamate in patients.

All 3 dose regimens were associated with reduced seizure rates per 28 days versus placebo. Following titration, investigators confirmed the recommended cenobamate dose is 200 mg daily.

Multiorgan hypersensitivity, as distinguished as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been previously reported among patients treated with cenobamate. In clinical trials assessing the drug, one patient died during a rapid titration period. However, no cases were reported in a 1339-patient open-label safety study assessing 12.5 mg therapy in patients with epilepsy.

Other common adverse events among patients treated with cenobamate included somnolence, dizziness, fatigue, diplopia, and headaches. As with other antiepileptic therapies, an increased risk of suicidal thoughts or behavior may occur in patients.

Billy Dunn, MD, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, praised the therapy for providing an additional treatment option to an at-need population.

"XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life," Dunn said in a statement. "Patients can have different responses to the various seizure medicines that are available.”