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FDA Approves Antiepileptic Drug for Age 4 and Older

Sunovion news release; 2017 Sep 14

Sunovion Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to expand the indication for its antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) to include treatment of partial-onset seizures (POS) in children and adolescents aged 4-17 years. Aptiom is also approved in the US for the treatment of POS in adults. Sunovion is headquartered in Marlborough, MA.

Indications: Aptiom is a once-daily, immediate release AED that is indicated for the treatment of partial-onset seizures in patients aged ≥4 years.

Dosage/administration:

  • Adults: Recommended initial dosage of Aptiom is 400 mg once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions. Increase the dose in weekly increments of 400 mg to 600 mg once daily, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1,600 mg once daily.
  • Pediatric patients: The recommended dosage is based on body weight and is administered orally once daily. Increase the dose in weekly intervals based on clinical response and tolerability, to the recommended maintenance dosage.

Adverse effects: Most common adverse reactions in adult patients receiving Aptiom include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions in pediatric patients are similar to those seen in adult patients.

Citation:

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. [news release]. Marlborough, MA: Sunovion Pharmaceuticals Inc. September 14, 2017. http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed September 27, 2017.

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FDA Approves Antiepileptic Drug for Age 4 and Older, Sunovion news release; 2017 Sep 14