Hatfield, England (ots/PRNewswire) Transparency advice for Zonegran(R) (zonisamide) monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy, has been published by the French National Authority for Health (HAS).[1] The Transparency Commission advice awards zonisamide a Medical Benefit (SMR) level of important and an Improvement of Medical Benefit (ASMR) level V. The advice recognises zonisamides level A efficacy rating.[2]
Once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AEDs.[3] Zonisamide is already available in France as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults over the age of 18.[3]
Monotherapy is the optimal treatment approach for newly diagnosed epilepsy, as most people with the condition may be successfully managed with the first or second monotherapy. In comparison with polytherapy, monotherapy also reduces the potential for adverse drug interactions.[4]
Zonisamides proven efficacy in the monotherapy setting makes it a welcome addition to doctors epilepsy treatment armamentarium in France, commented Professor Michel Baulac, Head of the Epilepsy department at the Pitie-Salpetrire Hospital, Paris, France.
Epilepsy is one of the most common neurological conditions in the world.[5] Around 450,000 people in France live with the condition, with over 100 new cases diagnosed each day.[6]
As a leader in epilepsy in Europe, Eisai is committed to not only bring innovative new therapies to market, but also ensure that we maximise the clinical benefits of our currently licensed products. We are pleased to introduce Zonegran as monotherapy for adults with newly diagnosed epilepsy in France, in addition to as adjunctive therapy for adults, commented Lysiane Bernal-Gallois, Chief Pharmacist, Eisai France.
The efficacy and safety of zonisamide as monotherapy has been demonstrated in a double-blind, randomised, multicentre 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 studys primary endpoint was the proportion of seizure-free patients for 26 weeks or more. Zonisamide demonstrated high seizure freedom rates in newly diagnosed patients with epilepsy,[7] 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 and was well tolerated after one year of treatment at doses ranging from 300 to 500 mg/day.
The use of adjunctive zonisamide in the treatment of partial seizures (with or without secondary generalisation) in children aged six years and above was approved by the European Commission in October 2013. Eisai has submitted a file to HAS in France for this new indication, with advice expected later this year.
The continued development of zonisamide underscores Eisais human health care (hhc) mission, the companys commitment to innovative solutions in 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 patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
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French Transparency Commission Recognises Efficacy of Zonegran (zonisamide) Monotherapy