The FDA has approved Briviact (brivaracetam) as adjunctive therapy for the treatment of partial-onset seizures in patients 16 years of age and older. Brivaracetam, a new molecular entity, has high and selective affinity for synaptic vesicle protein 2A in the brain, however the mechanism by which the drug exerts it anticonvulsant effects is unknown.
The approval of Briviact was based on the results of three Phase 3 clinical trials involving over 1500 participants. Taken with other medications, the drug was shown to be effective in reducing the frequency of seizures compared to placebo, with the most common side effects being drowsiness, dizziness, fatigue, nausea and vomiting.
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The FDA requires that Briviact be dispensed with a Medication Guide which provides information about uses and risks, including serious risks such as suicidal ideation and worsening depression and aggression; these risks are possible with any seizure medication. Another possible, but rare, side effect may be allergic reaction which may be associated with swelling of the lips, eyelids, or tongue with or without difficulty breathing.
“Patients can have different responses to the various seizure medicines that are available,” said Billy Dunn, MD, 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.”
The Drug Enforcement Administration (DEA) is anticipated to classify Briviact according to the drug scheduling process within the next 90 days, after which time Briviact will become commercially available in the U.S. in three formulations (film-coated tablets, oral solution, and injection).
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