Sunovion Pharmaceuticals announced its filing of a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for its drug Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures.
Aptiom is a voltage-gated sodium channel inhibitor that has previously received approval as an adjunctive treatment for epilepsy patients with partial-onset seizures not controlled by standard therapy. The company acquired rights to Aptiom through an exclusive license agreement with Portuguese pharma firm Bial.
Sunovion’s sNDA for Aptiom as monotherapy was supported by positive data from two randomized, double blind, Phase 3 trials, which involved patients 16 years old and above with partial-onset seizures that were still unmanageable following treatment with currently available antiepileptic drugs. The study’s primary endpoint was proportion of patients who met pre-defined exit criteria that signifies worsening seizure control 16 weeks post-titration of Aptiom compared to historical controls. The company presented the results of the two studies at the 68th Annual Meeting of the AES in Seattle this month.
Epilepsy is marked by the abnormal firing of impulses from nerve cells in the brain. Partial-onset epilepsy is characterized by abnormal bursts of electrical activity initially concentrated in certain parts of the brain, but which may spread in time. Reduction of seizures frequency will help lessen the burden of the disease in patients with epilepsy.
Fred Grossman, SVP of Sunovion Clinical Development and Medical Affairs, said, “Data from our monotherapy clinical trials build upon the established efficacy and safety of Aptiom adjunctive treatment. If approved for use as monotherapy, Aptiom would provide a new option for patients with partial-onset seizures.”
Earlier this year, Sunovion launched Aptiom in the U.S. in four tablet strengths. The drug is not classified as a controlled substance by the FDA. The company also received regulatory approval from Health Canada in July for Aptiom as a once-daily treatment for epileptic seizures.