Health Canada has accepted to review Sunovion Pharmaceuticals Canada's (Sunovion) new drug submission (NDS) for eslicarbazepine acetate for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients aged 18 years and above with epilepsy.
According to the company, the efficacy and safety of drug as an adjunctive or monotherapy treatment for partial-onset seizures in adults living with and affected by epilepsy has not yet been established.
Sunovion president Douglas Reynolds said the acceptance of the company's eslicarbazepine acetate submission is an important milestone for them and also for thousands of Canadians affected by epilepsy.
"Adequate seizure control remains an unmet medical need for a significant number of patients and Sunovion is committed to providing a treatment option to address this need," Reynolds added.
"If approved, eslicarbazepine acetate may offer adult patients an effective, adjunctive treatment option for better managing partial-onset seizures."
The NDS for the drug is supported by data obtained from three Phase III randomized, double-blind, placebo-controlled 12-week maintenance trials of similar study design, which included over 1,400 patients with partial-onset seizures.
Patients treated with the drug showed reductions in standardized seizure frequency when used as adjunctive therapy in these trials.
Epilepsy is a common set of chronic neurological disorders characterized by seizures, with abnormal firing of impulses from nerve cells in the brain.
