FDA Grants New Indication for Two Antiepileptic Drugs

Megan Brooks

Disclosures

September 15, 2017

The US Food and Drug Administration (FDA) has approved new indications for two antiepileptic drugs.

Brivaracetam (Briviact, UCB Inc) has now been approved as monotherapy for partial-onset (focal) seizures in children with epilepsy aged 16 years and older, and eslicarbazepine acetate (Aptiom, Sunovion) is now indicated for the treatment of partial-onset seizures in children as young as 4 years.

Last year, the FDA approved brivaracetam as adjunctive therapy for partial-onset seizures in patients aged 16 years and older with epilepsy, as reported by Medscape Medical News

"This new monotherapy indication builds on an already strong and compelling clinical profile for [brivaracetam], providing doctors the flexibility to tailor their choice of AED [antiepileptic drug] to match individual patient needs and circumstances," Pavel Klein, MD, director, Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland, said in a company news release. 

"In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day one, [brivaracetam] provides an additional treatment choice for neurologists and their patients," added Dr Klein.

Brivaracetam, a selective, high-affinity synaptic vesicle protein 2A ligand, is available in film-coated tablets, oral solution, and injection.

The most common adverse reactions (at least 5% for brivaracetam and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

Eslicarbazepine for Partial-Onset Seizures in Children

In related news, the FDA has expanded the indication for the antiepileptic eslicarbazepine acetate to include treatment of partial-onset seizures in children and adolescents aged 4 to 17 years.

The once-daily, immediate-release antiepileptic can be taken whole or crushed, with or without food.

Eslicarbazepine acetate is already approved in the United States for partial-onset seizures in adults.

"Despite being the most common seizure type in patients with epilepsy, there continues to be a critical need for new therapeutic options for partial-onset seizures, especially for children and adolescents," Steven Wolf, MD, director of pediatric epilepsy for the Mount Sinai Health System, New York City, said in a company news release.

"The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends and community. It is important that physicians have additional treatment options that address patient needs."

The approval to expand use of eslicarbazepine acetate to children aged 4 years and older is based on FDA guidance that permits the extrapolation of data to support pediatric use.

The safety and efficacy of the antiepileptic as monotherapy and adjunctive therapy for the treatment of partial-onset seizures in adults were established in five multicenter, randomized, controlled clinical trials.

Data from three clinical trials also supported the safety and tolerability of the agent for the treatment of partial-onset seizures in pediatric patients, the company said.

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