FDA

FDA Approves New Indications for 2 Epilepsy Treatments

The FDA has approved a new indication for brivaracetam as a monotherapy for partial-onset (focal) seizures (POS) in patients with epilepsy aged 16 years and older.

Brivaracetam was previously approved in the US as an adjunctive treatment for POS in patients in the same age group.
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Brivaracetam is the newest drug in the “racetam” class of medications, and is available as film coated tablets, oral solution, and injection. It does not require gradual dose escalation when initiating treatment, allowing for therapeutic doses to be given from the onset of treatment.

The most common adverse effects with brivaracetam are somnolence and sedation, dizziness, fatigue, and nausea and vomiting.

The FDA has also approved a new indication for eslicarbazepine acetate, which now includes treatment of POS in children and adolescents aged 4 to 17 years.

Eslicarbazepine acetate was previously approved in the US for the treatment of POS in adults. It is a once-daily, immediate release antiepileptic drug which can be taken whole or crushed, with or without food.

The most common adverse events reported with eslicarbazepine acetate are dizziness, sleepiness, nausea, headache, double vision, vomiting, problems with coordination, blurred vision, and shakiness.

—Michael Potts

Reference:

1. New indication for BRIVIACT® (brivaracetam): UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults [press release]. FDA. Atlanta, Georgia and Brussels, Belgium. September 15, 2017. https://www.ucb.com/stories-media/Press-Releases/article/New-indication-for-BRIVIACT-brivaracetam-UCB-s-newest-antiepileptic-drug-approved-by-FDA-as-monotherapy-treatment-of-partial-onset-seizures-in-adults.

2. Sunovion’s Aptiom (eslicarbazepine acetate) receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older [press release]. Marlborough, Massachusetts. September 14, 2017. http://www.sunovion.us/featured-news/press-releases/20170914a.pdf