FDA Approves New Option for Adults With Partial-Onset Seizures

XCOPRI (cenobamate tablets) has been approved by the US Food and Drug Administration for the treatment of partial-onset seizures in adults.

This approval comes after XCOPRI was found to be safe and effective in 2 randomized, double-blind, placebo-controlled trials including 655 adults with partial-onset seizures.

The most common side effects that patients in the clinical trials reported were somnolence, dizziness, fatigue, diplopia, and headaches.

“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,” said Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

—Amanda Balbi

Reference:

FDA approves new treatment for adults with partial-onset seizures [press release]. Silver Spring, MD: US Food and Drug Administration; November 21, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-partial-onset-seizures. Accessed November 21, 2019.