Date: 2016-04-18
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Academy of Neurology annual meeting
Company: Eisai (Japan) Bial (Portugal)
Product: Zebinix® (eslicarbazepine acetate)
Action
mechanism: antiepileptic drug. Eslicarbazepine acetate is a third generation, single enantiomer member of the dibenzazepine family of antiepileptic drugs, which includes carbamazepine and oxcarbazepine. Eslicarbazepine acetate was developed by Bial-Portela & Ca (Portugal). While oxcarbazepine is metabolized to both R- and the S-licarbazepine, as well as being detectible in serum as the parent compound, eslicarbazepine acetate is rapidly converted, primarily to S-licarbazepine (also known as eslicarbazepine), and is generally undetectable in serum as the parent compound. Eisai Europe Ltd. possesses the marketing rights to the product in Europe.
Disease: newly diagnosed partial-onset seizures
Therapeutic area: CNS diseases - Neurological diseases
Country:
Trial
details: This pivotal Phase III study is a randomised, double-blind, parallel-group, active-controlled and non-inferiority study, investigating the efficacy and safety of once-daily eslicarbazepine acetate (800 to 1600 mg/daily) as monotherapy treatment for newly diagnosed adults (18 years and older) with partial-onset seizures in comparison with twice-daily controlled-release carbamazepine (400 to 1200 mg/daily). The primary endpoint is the proportion of people seizure free for the entire 26-week evaluation period. Secondary endpoints include the time to first seizure, a QOLIE-31 quality of life assessment, and safety. The study examines data from 900 (815 available for efficacy and 813 available for safety analyses) newly diagnosed people (aged 18 and over) with epilepsy who experience partial-onset seizures, to evaluate eslicarbazepine acetate as a single treatment option.
Latest
news: * On April 18, 2016, BIAL and Eisai announced that new phase III data presented at the American Academy of Neurology (AAN) Annual Meeting show that once daily eslicarbazepine acetate monotherapy in adults with newly diagnosed partial-onset seizures is effective and well tolerated compared to twice daily controlled release carbamazepine at 6 months and 1 year of treatment. Positive results from a Bial sponsored Phase III study in adult patients with newly diagnosed partial-onset seizures show that treatment with once daily Zebinix® (eslicarbazepine acetate) monotherapy is as effective as twice daily controlled-release carbamazepine, a standard of care, and is well-tolerated. Eslicarbazepine acetate is currently indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.
Efficacy analysis from this study shows seizure freedom rates with eslicarbazepine acetate are similar to that of controlled-release carbamazepine ie; (71.1% versus 75.6%) in 785 eligible patients at ?6 months at the last evaluated dose (average risk difference -4.28%, 95%CI -10.3, 1.74%). The one-year seizure-free rate at the last evaluated dose was 64.7% in the eslicarbazepine acetate group and 70.3% in the controlled-release carbamazepine group (average risk difference: -5.46%; 95%CI: -11.88, 0.97%).
A safety analysis in 813 patients shows that once-daily eslicarbazepine acetate is well tolerated and side effects are mild to moderate. Incidence rates of treatment emergent adverse events (TEAEs) were similar but slightly lower in patients receiving eslicarbazepine acetate versus patients receiving controlled-release carbamazepine (77.8% vs 80.1% respectively). Possibly-related TEAEs for eslicarbazepine acetate were 43.6% compared with 51.5% for controlled release carbamazepine. Serious treatment-related TEAEs in eslicarbazepine acetate treated patients versus patients treated with controlled release carbamazepine were 2.0% vs 2.7% and for TEAEs leading to withdrawal were 13.5% vs 18%. The most frequently reported possibly-related TEAEs for eslicarbazepine acetate were headache, dizziness, nausea, fatigue, and somnolence.
