FDA/CDC

Aptiom approved for pediatric partial-onset seizures


 

The Food and Drug Administration has approved Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children aged 4-17 years, according to an announcement from Sunovion Pharmaceuticals.

The approval was based on results of three clinical trials where eslicarbazepine was shown to be safe and well tolerated in pediatric populations. The efficacy of eslicarbazepine has been illustrated in clinical trials in adult populations, and data were extrapolated to support usage in pediatric patients. Eslicarbazepine has previously been approved to treat partial-onset seizures in adults.

FDA icon Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
The precise mechanism of action of eslicarbazepine is unknown, but it is thought to involve the inhibition of voltage-gated sodium channels. The most common adverse events associated with eslicarbazepine are dizziness, sleepiness, nausea, headache, double vision, vomiting, feeling tired, problems with coordination, blurred vision, and shakiness. They are similar in both adult and pediatric patients.

Pediatric dosing of eslicarbazepine is based on weight, and the tablets, available in 200-mg, 400-mg, 600-mg, and 800-mg strengths, can be taken whole or crushed, with or without food, according to the prescribing information.

“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,” Steven Wolf, MD, director of pediatric epilepsy at Mount Sinai Health System, said in the announcement.
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