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FDA Approves New Seizure Drug
More than 60 million people worldwide suffer from epilepsy. The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.
Epilepsy is a brain disorder that causes people to have recurring seizures. A seizure is an episode, usually of relatively short duration, of abnormal brain activity. Seizures can cause a variety of symptoms, including uncontrolled movements or spasms, abnormal thinking and behavior, and abnormal sensations. Muscle spasms can be violent, and loss of consciousness can occur. A partial onset seizure begins in a limited area of the brain.
“Patients can have different responses to the various seizure medicines that are available,” said Billy Dunn, M.D., 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 has many possible causes including, among others, stroke, infection, tumors, traumatic brain injury, and abnormal brain development. In many cases, the specific cause is unknown.
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.
The most common side effects reported by people taking Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.
Briviact must be dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks.
Briviact is marketed by UCB, Inc. of Smyrna, Georgia.