Sunovion announced that the FDA has approved Aptiom (eslicarbazepine acetate tablets) as adjunctive treatment of partial-onset seizures. Aptiom contains eslicarbazepine acetate, a voltage-gated sodium channel inhibitor.
The approval is based on three Phase 3 randomized, double-blind, placebo-controlled, safety and efficacy trials that enrolled more than 1,400 patients with partial-onset seizures inadequately controlled by 1–3 concomitant antiepileptic drugs (eg, carbamazepine, lamotrigine, valproic acid, levetiracetam). In these studies, Aptiom demonstrated statistically significant reductions in standardized seizure frequency vs. placebo, and significantly more patients treated with Aptiom experienced seizure frequency reduction of >50% from baseline (41% Aptiom arm vs. 22% placebo arm).
Aptiom is being approved with a Medication Guide that provides important safety information to help patients avoid serious adverse events. Aptiom is expected to be available in the second quarter of 2014.
For more information call (888) 394-7377 or visit Aptiom.com.