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Swissmedic Approves Zonegran® (Zonisamide) Monotherapy Treatment For Epilepsy

Zonegran(R) (zonisamide) has been approved by Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy. 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.[1] 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.[2]

“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, Universit√© Paris VI.

Epilepsy is one of the most common neurological conditions in the world[3] with an estimated 70,000 people living with the condition in Switzerland alone[4]. 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[5].

“The approval of zonisamide monotherapy in Switzerland is a very welcome advance for both doctors and patients. The new extended monotherapy indication for Zonegran will provide patients with an alternative option to help improve their seizure control. The monotherapy indication will become an increasingly important option in the early treatment of ,” said Dr. Christiane Kordeuter, Medical Director, Eisai Switzerland. “Zonegran is one of only six AEDs available as monotherapy, allowing doctors to tailor treatment to individual patient needs.”

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,[6] 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 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 well being 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.

Source

1. Zonegran Summary of Product Characteristics

2. St. Louis, K. Rosenfeld. W. Bramley, T. Antiepileptic Drug Monotherapy: The Initial Approach in Epilepsy Management (2009) &(2): 77 – 72

3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010 (Accessed June 2011)

4. EPI Swiss Epilepsy Centre (Accessed August 2011)

5. Kwan P, Brodie MJ Early identification of refractory epilepsy. New England Journal of Medicine 2000; 342:314-9

6. Baulac, M. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology (2012), 11 (7) 579 – 588

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