Sunovion announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Aptiom (eslicarbazepine acetate) as monotherapy for the treatment of partial-onset seizures.
The FDA’s approval of Aptiom as monotherapy was supported by data from two Phase 3, dose-blinded, historical-controlled, multi-center, randomized clinical trials (Studies 093-045 and 093-046) that studied Aptiom (1200mg/day or 1600mg/day) as monotherapy for partial-onset seizures in patients ≥16 years old whose seizures were not well-controlled with other antiepileptics.
Across both studies, the primary endpoint was the percentage of patients who exited the study due to pre-defined criteria identifying worsening seizure control vs. historical controls from previous trials of patients converting to AED monotherapy. Study results showed that conversion to Aptiom monotherapy led to superior exit rates vs. historical controls in patients with partial-onset seizures who were not well-controlled by one or two current AEDs.
Aptiom, a dibenzazepine carboxamide antiepileptic, exerts anticonvulsant activity through inhibition of voltage-gated sodium channels. It is available as 200mg, 400mg, 600mg, and 800mg strength tablets.
For more information call (844) 427-8466 or visit Aptiom.com.