Sunovion Pharmaceuticals Inc. (Sunovion) announced today the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures. The sNDA was submitted to the FDA by Sunovion on October 29, 2014 and included data from two Phase 3 double-blind, historical-controlled, multi-center randomized trials involving patients with partial-onset seizures.

“APTIOM has been well-received for use as an adjunctive treatment in partial-onset seizures,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion. “We are pleased with the FDA’s acceptance of the filing for review and look forward to potential approval of APTIOM as monotherapy with once-daily dosing for patients with this complex neurological disorder.”

For more details, go to: http://www.sunovion.com/news/pressReleases/20150107.pdf