Final EPOS Study Results Published in Acta Neurologica Scandinavica Show Anti-epilepsy Treatment Zebinix® (Eslicarbazepine Acetate) Administered as Only Add-on to a Current Monotherapy Leads to High Retention and Seizure Freedom Rates and is Well-tolerate

HATFIELD, England, February 29, 2016 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS  

Final results of the European non-interventional study EPOS (Eslicarbazepine acetate in Partial-Onset Seizures) show that once-daily eslicarbazepine acetate can provide a significant decrease in seizure frequency and seizure freedom in many patients, and is well tolerated in clinical settings. The responder rate (proportion of patients with seizure reduction of 50% and above vs. baseline) at six months was 81.8%, with 39.2% of patients reporting seizure freedom. The retention rate after 6 months was high with 82.2%.Over the 6 month study period, the score of the quality of life inventory QOLIE-10 improved from 2.9 at baseline to 2.1 at study end, on group level. These data were published today in Acta Neurologica Scandinavica, one of the leading epilepsy journals.^[1]

EPOS is a non-interventional, multicentre, prospective study with adult patients suffering from partial-onset seizures insufficiently controlled by antiepileptic monotherapy (n=247). Retention, tolerability and safety, efficacy, as well as effects on health-related quality of life of eslicarbazepine acetate as only add-on therapy were assessed. The study was conducted in eight European countries (UK, Ireland, Denmark, Sweden, Norway, France, Czech Republic and Germany).^[1]

"The results show that with this add-on treatment, we can offer patients with focal epilepsy inadequately controlled by monotherapy a chance to improve their condition. The high retention rate reflects treatment satisfaction, and points to an efficacious and well tolerable therapy, which is easy to initiate. Approximately one third of people with epilepsy do not achieve seizure freedom with monotherapies, so there is a continued need for additional efficacious treatment options," comments Martin Holtkamp, Principal Investigator, University Hospital Charité, Germany.

Eslicarbazepine acetate, indicated in Europe as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalization^[2] is a once-daily drug and exerts its effect by a differential and selective action of its primary metabolite, eslicarbazepine, on sodium channels in their slow inactivated state. Eslicarbazepine acetate was approved by the European Commission in 2009 based on data submitted which showed that a significant therapeutic response could be reached by up to to 44% of difficult-to-treat patients with partial epilepsy.^[3] In long-term studies in patients with refractory epilepsy, it was shown that seizure freedom could be achieved by up to 12,5% of patients.^[4] Furthermore, experimental evidence documents an effect of eslicarbazepine in human brain tissue refractory to carbamazepine.^[5]