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Data Show Rufinamide, an Investigational Adjunctive Treatment for Lennox- Gastaut Syndrome, Reduced Drop Attacks by More Than 40%
Date:5/20/2008

om baseline was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%) (p<0.002). The rufinamide-treated patients had 42.5% median percentage reduction in tonic-atonic seizure (drop attack) frequency per 28 days from baseline as compared with 1.4% increase in the placebo-treated patients (p<0.0001). The rufinamide group had a statistically significant improvement in seizure severity (p<0.005) and a higher percentage of patients who experienced at least a 50% reduction in tonic-atonic seizure frequency per 28 days compared with placebo (42.5% vs 16.7; p=0.002). The common adverse events reported by more than 10% of patients receiving rufinamide and at a higher frequency than in placebo-treated patients were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%).

About Rufinamide

Rufinamide is a structurally novel compound that acts as a broad-spectrum anticonvulsant originally discovered and developed by Novartis Pharma AG. The New Drug Application (NDA) is pending review for safety and efficacy with the U.S. Food and Drug Administration. Eisai acquired an exclusive worldwide license to develop, manufacture and market rufinamide for any human therapeutic use with the exception of bipolar mood disorder, anxiety disorders and ophthalmologic disorders from Novartis Pharma AG in 2004.

About LGS

It is estimated that the incidence of LGS ranges from 1,400 to 4,500 new cases each year in the United States. Symptoms of LGS include a variety of seizure types, with tonic-atonic seizures being the most common. Atonic seizures (rapid loss of muscle tone and consciousness), and tonic seizures (where muscles contract continuously typically producing a stiffening of the legs and arms) lead to the sudden falls seen in LGS patients known as 'drop attacks.' Absence seizures (staring spells) and myoclonic seizures (sudden muscle jerks) are also commonly observed. All children with LGS will experience
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SOURCE Eisai Corporation of North America
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