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Title: Eldepryl Shows Encouraging Results In Alzheimer's Study
URL: http://www.pslgroup.com/dg/247E6.htm
Doctor's Guide
April 24, 1997


TAMPA, Fla., April 24, 1997 -- New information appearing in the April 24 issue of The New England Journal of Medicine indicates that Eldepryl(selegiline) may slow important functional signs and symptoms of Alzheimer's disease. The study was reported by the National Institute on Aging, part of the National Institutes of Health.

Scientists at 23 Alzheimer's Disease Cooperative Study (ADCS) sites in the United States conducted a double-blind, placebo-controlled, randomized, multicenter trial in 341 patients with Alzheimer's disease with moderate severity to determine if Eldeprylor alpha-tocopherol (vitamin E) slowed the progression of Alzheimer's disease.

The patients received one of the four possible treatments in the trial: Eldepryl (10 mg per day); vitamin E (2000 IU a day); Eldepryl and vitamin E; or placebo for two years.

Patients were assessed throughout the study to determine the progression of the disease, as measured by four practical and functional milestones: loss of ability to perform basic daily activities, institutionalization, progression to severe dementia and death. Both Eldepryl and vitamin E delayed the progression to these milestones by approximately seven months, compared to placebo therapy.

This study is the first to examine practical milestones in the Alzheimer's process, according to Melvin Sharoky, M.D., President of Somerset Inc., who developed the drug.

Somerset markets Eldepryl capsules, which are currently indicated as an adjunct in the management of Parkinson's disease patients being treated with levodopa or carbidopa/levodopa combinations. Eldepryl was approved in 1989 and is currently marketed as a 5 mg capsule taken twice a day. Since Eldepryl's approval, Somerset has continued to conduct research with various selegiline formulations for several diseases.

Somerset is currently conducting a phase III clinical trial in 406 Alzheimer's patients using its patented transdermal system. The transdermal system was chosen because it administers selegiline without a large production of selegiline metabolites, that are thought to reduce therapeutic benefit.

Somerset is owned by Mylan Laboratories, Inc. and by Watson Pharmaceuticals, Inc.

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