Swissmedic Approves Zonegran (zonisamide) Monotherapy Treatment for Epilepsy

15-Jul-2013 - United Kingdom
Zonegran (zonisamide) has today been approved by Swissmedic for the monotherapy treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. Monotherapy is when treatment is given with one single drug.
Already a successful add-on therapy, once-daily zonisamide is a second generation anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure which is unrelated to any other AEDs. For patients 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.
"Monotherapy is the optimal treatment approach for managing epilepsy and therefore the availability of zonisamide in this setting will provide newly diagnosed epilepsy patients with access to this already proven treatment as a first-line option in their care pathway," commented Professor Michel Baulac, Head of Neurology, Université Paris VI.
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 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.

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