Epileptic Seizure Drug Gets FDA Nod

The FDA has approved UCB’s brivaracetam (Briviact) as an adjunctive treatment for partial-onset seizures in patients aged 16 years and older with epilepsy.

The agency based its nod on data from 3 late-stage trials enrolling a total of 1550 patients. The research teams behind these studies found that Briviact taken along with other medications led to a reduction in seizures compared with placebo.

“The FDA’s approval of Briviact is significant because uncontrolled seizures can have serious, long-term effects, and approximately 30% of epilepsy patients remain uncontrolled on currently available treatments,” stated Pavel Klein, MD, the director of the Mid-Atlantic Epilepsy and Sleep Center in Bethesda, Maryland.

The most common adverse events reported by trial participants treated with Briviact include drowsiness, dizziness, fatigue, nausea and vomiting. Like many epilepsy treatments, the drug also carries risks for aggression, agitation, depression, panic attacks, and suicidal thoughts or attempts.

“Patients can have different responses to the various seizure medicines that are available,” noted Billy Dunn, MD, director of the FDA’s Division of Neurology Products, in a press release. “With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option.”

UCB plans to launch Briviact in the United States after the Drug Enforcement Administration classifies the drug, which is expected to happen within the next 90 days, according to a manufacturer press release. The drug will be available as a film-coated tablet, oral solution, and injection.