Sunovion Pharmaceuticals Inc. of Marlborough has submitted a supplemental new drug application to the Food and Drug Administration. The application seeks approval for the use of Aptiom for monotherapy treatment of partial-onset seizures in patients with epilepsy.
The prescription medicine is already approved for use as an adjunctive treatment of partial-onset seizures.
“Sunovion has a deep commitment to helping address the unmet medical needs of people living with partial-onset seizures,” Fred Grossman, senior vice president for clinical development and medical affairs at Sunovion, said in a statement. “Data from our monotherapy clinical trials build upon the established efficacy and safety of Aptiom adjunctive treatment.
Aptiom, eslicarbazepine acetate, is a voltage-gated sodium channel inhibitor.
