SK Life Sciences Seizure Drug Approved

FDA has approved a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults. Approval was based on data from two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. “In these studies, patients had partial-onset seizures with or without secondary generalization for an average of approximately 24 years and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period,” an agency release says. “During the trials, doses of 100, 200, and 400 mg daily of Xcopri reduced the percent of seizures per 28 days compared with the placebo group.”

FDA says the recommended maintenance dose following a titration period is 200 mg daily; however, some patients may need an additional titration to 400 mg daily, the maximum recommended dose, based on their clinical response and tolerability. The most common side effects that pwere somnolence, dizziness, fatigue, diplopia, and headaches.