Zonegran (zonisamide) has received reimbursement approval from The Spanish Directorate General of Pharmacy and Health Products, part of the Spanish Ministry of Health, as monotherapy in the treatment of partial seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial epilepsy in children and adolescents from six years old.

 

The antiepileptic drug (AED) has been promoted in Spain by Eisai’s partner, Esteve, since December 2013. Once-daily zonisamide is a second generation AED with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.

 

For people with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions and encourages treatment compliance. Epilepsy in children often presents major challenges such as developmental and behavioral problems that result in educational underachievement and a lack of self-esteem. These issues, which are frequently manifested in an attention deficit disorder, withdrawal, anxiety or depression, have a negative impact on both the child and their family.

 

“The availability of zonisamide in Spain as monotherapy in adults and the widened indication for its use as adjunctive therapy in children over the age of six and beyond is welcome and will provide a new treatment option for doctors and patients,” commented Dr. Pedro Serrano-Castro, department of neurology and neurophysiology, Hospital Torrecardenas, Spain.

 

“The extension of the Zonegran indication provides doctors with an effective and well-tolerated additional tool for the treatment of a condition that still poses many unsolved therapeutic challenges,” commented Dr. Pere Fernández, director of medical department & health innovation at Esteve.

 

Epilepsy is one of the most common neurological conditions in the world, with an estimated 400,000 people who currently live with epilepsy in Spain alone. The successful treatment of partial onset seizures (the most common type of epilepsy) remains a significant challenge and up to 30% of patients fail to achieve seizure freedom with existing AEDs.

 

The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomized, multicenter study of 583 newly diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. The study’s primary endpoint was the proportion of seizure-free patients at six months. Zonisamide demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy, similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonisamide was considered non-inferior to carbamazepine, was well tolerated and had no apparent safety concerns after one year of treatment at doses ranging from 300 to 500 mg/day.

 

The zonisamide pediatric approval was based on Study 312 (CATZ) published in Epilepsia in July 2013. These data from a double-blind, randomized, multicenter, placebo-controlled Phase 3 study, showed that significantly more patients responded positively to treatment with zonisamide (50%) versus treatment with placebo. The overall incidence of treatment-emergent adverse events (TEAEs) was similar for zonisamide versus placebo.

 

“As a research-based pharmaceutical company with a particular focus on epilepsy, we are not only committed to bringing innovative new therapies to market, but also ensuring that we maximise the clinical benefits of our currently licensed products. The new extended monotherapy and adjunctive therapy indication for Zonegran provides an alternative treatment option to help improve seizure control.” said Dr. Javier Sánchez, medical manager, Eisai Spain. “Zonegran is one of only six AEDs available as monotherapy, allowing doctors to tailor treatment to individual patient needs.”

 

The continued development of zonisamide underscores Eisai’s human health care mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of people with epilepsy and their families. Eisai is proud to market currently more epilepsy products in EMEA than any other company.

 

Date: February 19, 2014

Source: Eisai Europe Ltd.