Sunovion Receives Health Canada Approval For Aptiom In Epilepsy
Sunovion Pharmaceuticals recently announced that it has received approval from Health Canada for Aptiom (eslicarbazepine acetate) as a once-daily treatment for epileptic seizures.
Aptiom is a voltage-gated sodium channel inhibitor indicated as adjunctive treatment for epilepsy patients with partial-onset seizures not controlled by standard therapy. The drug received approval from the U.S. Food and Drug Administration (FDA) last year. Aptiom was originally developed by Portuguese pharmaceutical company BIAL and later acquired by Sunovion. It is marketed by Eisai under the name Zebinix in the EU.
Commenting on the Canadian approval, Sunovion Pharmaceuticals Canada President Douglas Reynolds said, “The approval of Aptiom is an important milestone not only for our company, but for thousands of Canadians living with, and 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.”
Partial-onset seizures result from bursts of electrical activity in certain areas of the brain. These may become increasingly widespread later on depending on the extent and location of the affected brain areas. Epilepsy affects 0.6 percent of the Canadian population, with around 15,500 new diagnoses every year. One-third of patients with partial-onset seizures lack satisfactory seizure control.
The Health Canada approval was based on three safety and efficacy Phase 3 trials. These involved over 1,400 patients insufficiently controlled by one to three concomitant AEDs, including carbamazepine, lamotrigine, valproic acid and levetiracetam. Results showed that Aptiom achieved greater reductions in seizure frequency from baseline compared to placebo.
Earlier this year the company presented data on another of its brain disease drugs at the 167th annual meeting of the American Psychiatric Association. Sunovion presented research regarding its atypical antipsychotic agent Latuda (lurasidone HCI) for the treatment of patients with major depressive episodes linked with bipolar depression.