FDA Approves Brivaracetam (Briviact) for Partial-Onset Seizures

Treatment indicated for patients 16 years of age and older with epilepsy

The FDA has given the nod to brivaracetam (Briviact, UCB, Inc.), a high-affinity synaptic vesicle protein 2A (SV2A) ligand, as an add-on treatment to other medications to treat partial-onset seizures in patients 16 years of age and older with epilepsy.

Epilepsy has many possible causes, including stroke, infection, tumors, traumatic brain injury, and abnormal brain development. In many cases, the specific cause is unknown. Epilepsy is one of the most common conditions affecting the brain. Approximately 5.1 million people in the U.S. have a history of epilepsy, and approximately 2.9 million people in the U.S. have active epilepsy.

The efficacy of brivaracetam was studied in three clinical trials involving a total of 1,550 subjects. The medication was shown to be effective in reducing the frequency of seizures. The most common adverse events included drowsiness, dizziness, fatigue, nausea, and vomiting.

Brivaracetam 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.

Source: FDA; February 19, 2016.