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news.US-based Sunovion Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking approval for the use of Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures.
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The sNDA for a monotherapy indication is based on data from two double-blind, historical-controlled, multicenter randomized, Phase III trials (093-046 and 093-045) with identical study designs.
The trials were designed to evaluate the safety and efficacy of Aptiom as monotherapy treatment for partial-onset seizures in patients 16 years of age or older who were not well-controlled by other current antiepileptic drugs (AEDs).
Primary endpoint of the two trials was the proportion of patients with partial-onset seizures meeting pre-defined exit criteria 16 weeks post-titration of Aptiom, in comparison to historical controls.
Sunovion Clinical Development and Medical Affairs senior vice-president Fred Grossman said: "Sunovion has a deep commitment to helping address the unmet medical needs of people living with partial-onset seizures.
"Data from our monotherapy clinical trials build upon the established efficacy and safety of Aptiom adjunctive treatment. If approved for use as monotherapy, Aptiom would provide a new option for patients with partial-onset seizures."
Currently, Aptiom is approved for use as adjunctive treatment of partial-onset seizures and is not approved for use as monotherapy treatment.
Aptiom is a prescription medicine approved for use as adjunctive treatment of partial-onset seizures, and is available in four tablet strengths 200mg, 400mg, 600mg and 800mg.