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FDA has approved brivaracetam (Briviact, UCB, Inc.) as an add-on therapy for the treatment of partial onset-seizures in patients with epilepsy.
The drug was also approved by the European Commission in January. In trials, brivaracetam significantly reduced the frequency of seizures compared to placebo, with a 50% reduction in seizures seen in up to 40% of patients treated with Briviact, UCB said at the time.
The Drug Enforcement Administration is anticipated to classify Brviact according to the drug scheduling process within the next 90 days, after which time the drug will become commercially available in the United States.
“The FDA’s approval of Briviact is significant, because uncontrolled seizures can have serious, long-term effects, and approximately 30% of epilepsy patients remain uncontrolled on currently available treatments,” said Dr. Pavel Klein, MD, director, Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Md.
For the US approval, Briviact’s effectiveness was studied in three clinical trials involving 1,550 participants. When taken along with other medications, Briviact was effective in reducing the frequency of seizures.
Briviact is available in three formulations, including film-coated tablets, oral solution, and solution for injection/infusion. Briviact does not require titration, meaning that patients may receive a therapeutic dose of the drug from the first day of treatment. Physicians can also individualize the patient’s dose based on their response and tolerability.
“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 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 most common side effects associated with the use of Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.
FDA will require that Briviact be dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks. As with all medications used to treat epilepsy, these risks include increased suicidal ideation, feelings of agitation, and new or worsening depression, aggression and panic attacks.