Sunovion Pharmaceuticals Inc. announces that Health Canada has approved the use of Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures in adults with epilepsy. All patients who participated in the monotherapy trial were newly or recently diagnosed with epilepsy.
Aptiom is now indicated in Canada as monotherapy and as adjunctive therapy for the treatment of partial-onset seizures (POS) in adults with epilepsy.
“Partial-onset seizures are the most common type of seizures experienced by people living with epilepsy and, given their unpredictable nature, can have a significant impact on their life,” says Eduard Bercovici, M.D., Epileptologist, director of the Southern Ontario Epilepsy Clinic. “This new indication for Aptiom in Canada helps to provide an additional treatment option for health care professionals and patients with partial-onset seizures.”
The SNDS approval is supported by data from a Phase 3, double-blind, active-controlled, non-inferiority study in which Aptiom met its primary efficacy endpoint of non-inferiority to the active comparator, carbamazepine controlled release (CBZ-CR).
“APTIOM’s approval in Canada as a once-daily, monotherapy treatment option for adults living with partial onset seizures is a significant milestone in Sunovion’s commitment to the epilepsy community and improving the lives of people affected by neurological conditions,” says David Frawley, executive vice president and chief commercial officer at Sunovion. “We are pleased to offer Aptiom as a new monotherapy treatment option for even more adults living with epilepsy and partial-onset seizures, which can be challenging to manage.”
Phase 3 was a double-blind, active-controlled, non-inferiority study, consisting of 813 adults that were newly or recently diagnosed with epilepsy. They received either Aptiom (800, 1200 or 1600 mg, once-daily) or the active comparator carbamazepine controlled release (CBZ-CR; 200, 400 or 600 mg, twice-daily). All patients were randomized to the lowest dose level of each drug and only escalated to the next dose level if a seizure occurred. Aptiom met its primary efficacy endpoint of non-inferiority to CBZ-CR. In the primary efficacy analysis, 71.1 per cent of the patients were classified as seizure-free in the Aptiom group and 75.6 per cent in the CBZ-CR group within the 26-week evaluation period.
The most common treatment-emergent adverse events (TEAEs) reported for APTIOM included dizziness (13.7 percent) and headache (22.9 percent), but Aptiom was generally well-tolerated across the general population of patients. The study (BIA-2093-311) was conducted by Sunovion’s partner, BIAL, a privately held Portuguese research-based pharmaceutical company.