FDA Announces Approval for Briviact to Treat Partial Onset Seizures

FDA Announces Approval for Briviact to Treat Partial Onset Seizures
Image: Pixabay
February 19, 2016

The Food and Drug Administration (FDA) has approved Briviact (brivaracetam) to treat partial onset seizures resulting from epilepsy. The drug is intended for use in patients over the age of 15 and should be used as an add-on treatment to other medications.

"Patients can have different responses to the various seizure medicines that are available," said Billy Dunn, in a written statement. Dunn is the director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option."

Epilepsy is a brain disorder that causes people to have recurring seizures. A seizure is an episode of abnormal brain activity, typically short in duration. Seizures can result in a variety of symptoms, including uncontrolled movements or spasms, abnormal thinking and behavior, and abnormal sensations.

Epilepsy is one of the most common conditions affecting the brain. About 2.9 million people in the United States have active epilepsy, while about 5.1 million have a history with the condition.

Briviact's effectiveness was studied in three clinical trials involving 1,550 participants. Briviact, taken along with other medications, was shown to be effective in reducing the frequency of seizures. According to Medscape, the trial showed, for recipients of the 100-mg dose, a 22.8 percent reduction in seizure frequency compared to placebo. That figure jumped to 23.2 percent for those taking a 200-mg dose.

In addition to the clinical evidence, brivaracetam has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.

The most common side effects reported by people taking Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.

Briviact is marketed by UCB Biosciences.