Sunovion announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures.
The sNDA submission for a monotherapy indication includes data from two Phase 3, double-blind, historical-controlled, multicenter randomized trials with identical study designs. The objective of the studies was 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). The primary endpoint of both studies was the proportion of patients with partial-onset seizures meeting pre-defined exit criteria (signifying worsening seizure control) 16 weeks post-titration of Aptiom, in comparison to historical controls.
Aptiom is already indicated for adjunctive treatment of partial-onset seizures.
For more information call (800) 739-0565 or visit Sunovion.com.