09/03/2015


 Once-daily, non-extended release antiepilepsy drug now FDA-approved as both monotherapy and adjunctive therapy for partial onset seizures
Monday, August 31, 2015

Marlborough, MA – Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Aptiom® (eslicarbazepine acetate) as monotherapy for the treatment of partial-onset seizures. This new approved indication allows APTIOM to be used as monotherapy in people who initiate treatment for the first time or convert from other antiepileptic drugs (AEDs) to APTIOM. Previously approved in 2013 by the FDA as adjunctive therapy for partial-onset seizures, APTIOM is the only exclusively once-daily, non-extended release AED, which can be used alone or in combination with other AEDs in the treatment of partial-onset seizures.

“Epilepsy specialists appreciate the approval of APTIOM as monotherapy for focal onset seizures because it can be dosed once per day which is more convenient for patients,“ said Nathan Fountain MD, chair of the Epilepsy Foundation Professional Advisory Board. 

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