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Eisai Inc. Release: New Data Suggest Zonegran(R) (Zonisamide Capsules) Reduced Seizure Frequency In Pediatric Epilepsy Patients


10/19/2005 5:11:52 PM

OTTAWA, Oct. 18 /PRNewswire/ -- New data presented today suggest Zonegran reduced seizure frequency, and in some cases eliminated seizures, in infants 12 months of age and younger. Findings from this open-label, retrospective chart review were reported at the Child Neurology Society 33rd Annual Meeting by Angus Wilfong, M.D., Texas Children's Hospital, Division of Child Neurology, Baylor College of Medicine. Zonegran (zonisamide capsules) 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.

"This study suggests that Zonegran may be effective and well tolerated in infants with severe epilepsy," said Dr. Wilfong. "These findings were consistent with prior studies suggesting zonisamide is effective in pediatric patients with various seizures types." Dr. Wilfong also concluded further investigation of Zonegran for infants with epilepsy is warranted.

Researchers collected data from 50 patients, with a mean age of seven months. Patients were evaluated based upon caregiver reports. All patients were treated at a university-based pediatric neurology clinic. Twenty-nine patients (58 percent) experienced at least a 50 percent reduction in seizure frequency. Fourteen patients (28 percent) were seizure-free while taking Zonegran.

The majority of patients (n=29) had symptomatic generalized epilepsy (epilepsy with an identifiable cause involving both sides of the brain); other patients had cryptogenic generalized epilepsy (epilepsy with an unknown cause involving both sides of the brain) (n=11), symptomatic localization-related epilepsy (epilepsy with an identifiable cause involving one or more distinct parts of the brain) (n=6), or cryptogenic localization-related epilepsy (epilepsy with an unknown cause involving one or more distinct parts of the brain) (n=4). Mean final dosage of Zonegran was 18.9 mg/kg per day.

Adverse events were mild and included appetite suppression, irritability, sedation and vomiting. Most adverse events resolved within two to four weeks. Only three patients in the study discontinued Zonegran, and this was due to anorexia with weight loss. No patient experienced renal stones, oligohidrosis or hyperthermia, and no patients discontinued treatment due to rash.

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 all partial seizures in adults with epilepsy.

Zonegran is a sulfonamide. Hypersensitivity or other serious reactions may occur. Serious skin and hematologic reactions have occurred. Physicians should consider discontinuing the drug in patients who develop an otherwise unexplained rash. Oligohidrosis 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.

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/.

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.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care company that discovers, develops and markets products in more than 30 countries. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1.7 billion in fiscal year 2003 (year ending March 31, 2004).

Eisai Inc. employs approximately 1,100 people at its headquarters in Teaneck, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. Between 1998 and 2003, Eisai Inc. moved up rapidly in the rankings (based on revenues) of U.S. pharmaceutical companies from No. 44 to No. 20.

Eisai Inc.

CONTACT: Judee Shuler of Eisai Inc., +1-201-287-2241, or cell,+1-908-337-2540, or Judee_Shuler@eisai.com; or Krysta Walkowiak of DorlandGlobal Health Communications, +1-415-262-5211, or kwalkowiak@dorland.com, forEisai Inc.


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