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Title: Zonegran (Zonisamide) Appears to Reduce Complex Partial Seizure Frequency in Patients With Partial Epilepsy: Presented at AES

"Zonegran (Zonisamide) Appears to Reduce Complex Partial Seizure Frequency in Patients With Partial Epilepsy: Presented at AES"

NEW ORLEANS, LA -- December 6, 2004 -- New data presented today suggest Zonegran (zonisamide) capsules significantly reduced frequency of complex partial seizures in patients with refractory epilepsy involving one or more distinct parts of the brain. Findings from this randomized, double-blind, placebo-controlled trial were reported at the American Epilepsy Society's 58th Annual Meeting. Zonegran is an anti-epileptic drug approved by the U.S. Food and Drug Administration as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. "These findings further support Zonegran's effectiveness and tolerability as adjunctive therapy in patients who suffer from inadequately controlled partial seizures," said Stephen Wroe, M.D., Department of Clinical Neurology, Ipswich Hospital, U.K. "The study found that dosing as high as 500mg/day was effective in reducing seizures in this population." Researchers studied 351 patients with refractory partial seizures receiving one or more anti-epileptic drugs. Patients were randomized to receive placebo or 100mg, 300mg or 500mg Zonegran in an upward-dose titration period (the initial dose was increased) that lasted greater than or equal to six weeks, followed by an 18-week fixed-dose assessment phase. The two primary efficacy parameters for this study were: a) A percentage of change in seizure frequency from baseline to a fixed dose assessment phase between 500 mg/day Zonegran and placebo and; b) A proportion of responders defined as patients with a 50% or greater decrease from baseline in seizure frequency during the fixed dose assessment phase. Results from the study demonstrated that both 500mg/day (p<.0001) and 300mg/day (p=.0005) doses of Zonegran were statistically superior to placebo in reducing the frequency of complex partial seizures. Responder rates (patients who experienced a 50 percent or greater reduction in seizures) showed a significant linear-dose relationship, with 52.5 percent, 42.2 percent, 29.6 percent and 17.9 percent of patients responding to Zonegran 500mg, 300mg, 100mg and placebo, respectively. Zonegran was generally well-tolerated at all doses, with adverse events occurring in a similar proportion to patients receiving placebo. The most common treatment-emergent adverse events seen in this trial (a 5% or higher incidence in any Zonegran group compared to placebo) were anorexia, headache, dizziness, insomnia, nausea and somnolence. Most patients reported at least one adverse event, and most adverse events were mild to moderate. Researchers concluded that Zonegran is dose-dependent, effective and generally well-tolerated adjunctive therapy for patients with refractory partial seizures. Information about Zonegran (zonisamide capsules) Zonegran is an anti-epileptic drug approved in March 2000 by the U.S. Food and Drug Administration (FDA) as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. In Europe, a Marketing Authorization Application was submitted through the European Union's (EU's) Centralized Procedure in November 2003. Zonegran is a sulfonamide. Hypersensitivity or other serious reactions may occur. Serious skin and hematologic reactions (in the blood or blood-forming organs) have occurred. Physicians should consider discontinuing the drug in patients who develop an otherwise unexplained rash. Oligohidrosis (decreased sweating) has been reported in association with Zonegran therapy in pediatric patients. Zonegran is not approved for pediatric patients under the age of 16. Kidney stones have been reported in patients receiving Zonegran therapy. Patients should take special care when driving or if they operate complex machinery until they know how Zonegran may affect their performance. In clinical trials, the most commonly reported adverse events were somnolence, dizziness, anorexia, headache, nausea and agitation/irritability. For more information about managing epilepsy and about Zonegran, and for full prescribing information for Zonegran, please call 1-888-274-2378 or visit http://www.eisai.com. Please also see accompanying prescribing information. Eisai acquired exclusive North American and European manufacturing and marketing rights to Zonegran from Elan in 2004. Elan had previously licensed Zonegran from Dainippon Pharmaceutical Co., Ltd. In Japan, the product is marketed by Dainippon under the brand name Excegran. SOURCE: Eisai Inc.

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