Epilepsy Foundation applauds the U.S. Food and Drug Administration (FDA) for approving Briviact (brivaracetam) as an add-on therapy to other medications to treat partial onset seizures in people age 16 years and older with epilepsy.

"We are thrilled to see another drug become available to our patients who desperately need new therapies," said Jacqueline French, MD, chief scientific officer of the Epilepsy Foundation and professor of neurology at New York University. "We are excited to see how this new therapy works in the clinic, and over time, with expanded use, we will be able to determine which patients will most benefit. Every new therapy that is approved may represent an opportunity for patients to experience improved seizure control, and better quality of life."

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 epilepsy community welcomes brivaracetam as a new therapy that is available to people with epilepsy who have not responded to other treatments,” said Nathan B. Fountain, MD, chair of the Epilepsy Foundation’s Professional Advisory Board and professor of neurology at the University of Virginia. “About half of people with epilepsy do not respond to the first drug and about a quarter persist in having seizures despite trying many drugs. However, many of these people will find a particular drug or drug combination that will help, and having more drugs available for this purpose is a step forward.”

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. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks. Rarely, patients may exhibit an allergic reaction associated with swelling of the lips, eyelids, or tongue with or without difficulty breathing.

Briviact, marketed by UCB, Inc. of Smyrna, Georgia, is expected to be available to consumers within 90 days.