Sunovion Pharmaceuticals, Inc. announced that FDA approved the supplemental New Drug Application for Aptiom (eslicarbazepine acetate) as monotherapy for the treatment of partial-onset seizures. This new approved indication allows Aption to be used as monotherapy in people who initiate treatment for the first time or convert from other antiepileptic drugs to Aptiom.
Dosage and Administration: The 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 1600 mg once daily.
• Patients with moderate or severe renal impairment: Reduce dosage by 50%.
Adverse Events: Most common adverse reactions in patients receiving Aptiom (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.
Citation: Sunovion announces FDA approval of a new indication for Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures. [news release]. Marlborough, MA: Sunovion; August 28, 2015: http://www.sunovion.com/news/pressReleases/20150828.pdf. Accessed September 2, 2015.