Placebo-Controlled Study Results Published in May 20 Issue of Neurology
WOODCLIFF LAKE, N.J., May 20 /PRNewswire/ -- Eisai Corporation of North America announced today the publication of a placebo-controlled study in Neurology that found patients with Lennox-Gastaut syndrome (LGS) treated with the investigational antiepileptic agent rufinamide as adjunctive therapy experienced more than 40% fewer drop attacks than patients who received placebo (increase of 1.4%). The differences between rufinamide and placebo were observed as early as week two of the study. LGS is a severe form of generalized epilepsy that develops in early childhood and is characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury.
"Lennox-Gastaut syndrome is a devastating form of pediatric epilepsy usually resulting in multiple seizures occurring several times a day and is often associated with impaired mental development," said the study's lead author Tracy Glauser, MD, Director, Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center, Ohio. "Existing antiepileptics offer limited seizure control and there may be difficulties with tolerability."
The study was a multicenter, double-blind, placebo-controlled, randomized, parallel-group study. Male and female patients (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant stable dose antiepileptic drugs (AEDs). Each patient must have had at least 90 seizures in the 28-day baseline period prior to study entry. One hundred thirty-nine eligible patients were randomized; 138 patients received either rufinamide (titrated up to 45mg/kg per day) (n=74) or placebo (n=64) in addition to their other AEDs.
The median percentage reduction in total seizure frequency from 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%).
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.
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 varying degrees of developmental delay and behavioral problems.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: neurology, gastrointestinal disorders and oncology/critical care. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. More than 50 percent of the group sales are derived from overseas business. For more information, please visit http://www.eisai.co.jp.
|SOURCE Eisai Corporation of North America|
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