The US Food and Drug Administration (FDA) has approved brivaracetam (Briviact, UCB Inc) as adjunctive therapy for partial-onset seizures (POS) in patients age 16 years and older with epilepsy.
In the United States, an estimated 5.1 million people have a history of epilepsy and roughly 2.9 million people have active epilepsy, the FDA notes.
"Patients can have different responses to the various seizure medicines that are available. With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option," Billy Dunn, MD, director, Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a press release.
Brivaracetam, a selective, high-affinity synaptic vesicle protein 2A ligand, is an analogue of the already available antiepileptic drug levetiracetam. Brivaracetam was studied in three clinical trials involving 1550 participants. When taken along with other medications, the drug was effective in reducing the frequency of seizures, the FDA said.
For example, as reported previously by Medscape Medical News, one phase 3 trial included 768 patients aged 16 to 80 years with drug-resistant POS at 206 sites in countries across North and South America, Europe, and Asia. Patients were randomly allocated to placebo (n = 263), brivaracetam at 100 mg/day (n = 254), or brivaracetam at 200 mg/day (n = 251).
For both doses of the drug, the co-primary efficacy outcomes were statistically significant (P < .001) compared with placebo.
The percentage reduction over placebo in the 28-day adjusted POS frequency was 22.8% for the 100-mg group and 23.2% for the 200-mg group. The other co-primary outcome — a 50% or greater responder rate for POS frequency — showed that this rate was 21.6% for placebo vs, versus 38.9% for the 100-mg dose (P < .001) and 37.8% for the 200-mg dose (P < .001).
The median percentage reduction in POS frequency was 37.2% for the 100-mg dose and 35.6% for the 200-mg dose compared with 17.6% for placebo (both P < .001). Another secondary outcome was seizure freedom during the 12-week treatment period. It was 0.8% in the placebo, 5.2% (P < .003) in the 100-mg, and 4.0% (P < .019) in the 200-mg group.
In clinical trials, brivaracetam was well tolerated, with relatively low rates of discontinuation. The most common adverse effects reported by people taking the drug in clinical trials included drowsiness, dizziness, fatigue, nausea, and vomiting.
The FDA will require that brivaracetam 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," the FDA said.
Brivaracetam has also been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as adjunctive therapy for partial-onset seizures with or without secondary generalization in adult and adolescent patients 16 years of age and older with epilepsy.
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Cite this: FDA Clears Brivaracetam (Briviact) for Partial-Onset Seizures - Medscape - Feb 19, 2016.