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Briviact FDA-Approved For Pediatric Patients with Partial-Onset Seizures

Natan Rosenfeld Natan Rosenfeld September 10, 2021

Briviact, the latest treatment for partial-onset seizures in young patients, has recently been approved by the FDA. The therapy, available orally or intravenously, has shown to be effective in reducing the number of seizures in children as young as one month of age.


Effectiveness of Briviact


In an open label follow-up pediatric study of children aged 1 month to 17 years, Briviact led to long-term seizure retention rates over a two-year time span. 71.4% of patients aged 1 month and 64.3% of patients aged 17 or younger remained on Briviact after 1 and 2 years of treatment, respectively. 


“We often see children with seizures hospitalized, so it’s important to have a therapy like Briviact IV that can offer rapid administration in an effective dose when needed and does not require titration. The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” said Raman Sankar, MD, PhD, FAAN, FAES, Distinguished Professor and Chief of Pediatric Neurology at the Rubin Brown Endowed Chair for the David Geffen School of Medicine at UCLA and UCLA Mattel Children’s Hospital. 


“Now that Briviact IV and oral formulations are an approved therapy for partial-onset seizures in children as young as one month, we have a new option that helps meet a critical need in pediatric epilepsy.”


Side effects of Briviact


Although Briviact is considered safe to administer, patients may experience side effects such as sedation, dizziness, fatigue, nausea, and vomiting. However, the drug has also been reported to cause psychotic symptoms and suicidal thoughts. 13% of adult patients taking Briviact reported having an adverse psychiatric reaction. Patients experiencing these symptoms should contact their healthcare provider immediately.


Nonetheless, the benefits of Briviact appear to outweigh any potential risk of side effects. “The pediatric safety and tolerability data for BRIVIACT and the FDA-approved indication for treating partial-onset seizures in children as young as one month supports clinical decision-making for healthcare providers,” said John J. Millichap, MD, FAAN, FAES, Pediatric Epileptologist and Adjunct Associate Professor of Neurology at Northwestern University Feinberg School of Medicine.

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