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news.The US Food and Drug Administration (FDA) has accepted to review Sunovion Pharmaceuticals' supplemental new drug application (sNDA) for the use of Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures.
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Aptiom is approved for use as adjunctive treatment of partial-onset seizures and is not approved for use as monotherapy for partial-onset seizures.
The sNDA included data from two designed identically Phase III double-blind, historical-controlled, multi-center randomized trials involving patients with partial-onset seizures.
The two trials (093-046 and 093-045) assessed the safety and efficacy of Aptiom 1,600mg/day or 1,200mg/day as monotherapy treatment in patients 16 years of age or older whose seizures were not well-controlled by other antiepileptic drugs (AEDs).
Sunovion executive vice-president and chief medical officer Dr Antony Loebel said: "Aptiom has been well-received for use as an adjunctive treatment in partial-onset seizures."
All patients in the 093-045 study were evaluated in North America, while study 093-046 included around 25% of patients from the US and about 75% from four European countries.
Primary endpoint in 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.