FDA approves new treatment for adults with partial-onset seizures

FDA on Thursday approved cenobamate tablets (XCOPRI—SK Life Science) to treat partial-onset seizures in adults.

FDA on Thursday approved cenobamate tablets (XCOPRI—SK Life Science) to treat partial-onset seizures in adults. The tablets are "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," said Billy Dunn, MD, director of the Office of Neuroscience in FDA's Center for Drug Evaluation and Research. "Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition." Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial-onset seizure begins in a limited area of the brain. The safety and efficacy of cenobamate tablets to treat partial-onset seizures was established in two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. The recommended maintenance dose of cenobamate tablets, following a titration (medication adjustment) 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 adverse events that patients in the clinical trials reported were somnolence (sleepiness), dizziness, fatigue, diplopia (double vision), and headaches.