The US FDA has approved UCB’s Briviact (brivaracetam) as adjunctive therapy for the treatment of partial-onset seizures in patients 16 years and older. The drug should become available within the next 3 months.
Similar to Keppra (levetiracetam, UCB), Briviact targets the synaptic vesicle protein 2A; however this formulation is said to have a higher affinity for this target.
The drug was evaluated in 3 clinical trials involving 1550 participants, with seizure frequencies reduced by 23% in the treatment group and a responder rate of just under 40% recorded in the final phase 3 trial.
“Patients can have different responses to the various seizure medicines that are available,” Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option.”
The most common adverse reactions observed in treatment groups taking at least 50 mg/day included somnolence and sedation, headache, dizziness, fatigue, nausea and vomiting, irritability, insomnia, depression, and anxiety. The discontinuation rate due to adverse events was 5%, 8%, and 7% for patients randomized to 50 mg, 100 mg, and 200 mg/day of Briviact, respectively.
The drug, which has previously been approved by the European Commission, will be available in film-coated tablets, oral solution, and injection.
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