Phase III trial of YKP 3089 reveals adverse event in epilepsy.- SK Life Science.

SK Life Science announced results of a large, Phase III, multicenter, open-label safety study of its lead investigational antiepileptic drug, YKP 3089 (cenobamate). Two previous pivotal, randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of cenobamate in adult patients with partial-onset seizures. During this clinical development program, a serious, delayed hypersensitivity adverse event, DRESS (drug reaction with eosinophilia and systemic symptoms) syndrome, emerged.

The large, international, multicenter, open-label safety study was designed to mitigate the rate of DRESS syndrome. No cases of DRESS syndrome were identified in 1,339 patients exposed to cenobamate using a lower starting dose and slower titration. Patients in the safety study were 18-70 years old and taking stable doses of one to three antiepileptic drugs. Increasing daily doses of cenobamate were administered (12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg/day) at two-week intervals with further increases to 400 mg/day using biweekly increments of 50 mg/day allowed. The most common adverse events were somnolence, dizziness and fatigue. Serious adverse events, with hospitalizations for seizure being the most common, were observed in 114 (8.5%) patients who had treatment-resistant partial seizures taking multiple antiepileptic drugs. Data were presented at the American Epilepsy Society Annual Meeting.