Aricept ODT
donepezil HCl
Treatment for Alzheimer's DiseaseEisai Submits Application to FDA for Aricept for Treatment of Severe Alzheimer's Disease
RIDGEFIELD PARK, N.J., September 01, 2005 -- Eisai Co., Ltd. and Eisai Inc. (Headquarters: Teaneck, NJ, Chairman and CEO Hajime Shimizu) announced today that on their behalf, Eisai Medical Research Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, MD) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Aricept (donepezil HCl tablets) for treatment of severe Alzheimer's disease (AD). Aricept, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc, is currently approved for treatment of mild to moderate AD.
"Our goal to provide Aricept to people with severe Alzheimer's disease is consistent with Eisai's human health care mission to improve the lives of patients and their families," said Lonnel Coats, president and COO, Eisai Inc.
The August 31 submission is based on data from a six-month, multi-center, randomized, double-blind, placebo-controlled clinical trial conducted in approximately 250 nursing home patients with severe AD. In the pivotal study, patients with severe AD (Mini Mental State Examination scores 1-10) treated with Aricept had a statistically significant improvement compared to those taking placebo on both primary measures of efficacy: the Severe Impairment Battery (SIB scale) and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS ADL severe scale). The SIB measures cognition in a more severe population. The ADCS ADL measures patient function and ability to conduct activities of daily living.
Treatment with Aricept (donepezil HCl tablets) was generally well tolerated. The most common adverse events in Aricept-treated patients reported at more than twice the rate of placebo-treated patients were diarrhea and hallucinations. The rate of discontinuation for adverse events was greater in the Aricept-treated patients than in the placebo-treated patients (15.6 % vs 6.7%).
AD is a progressive brain disease that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. AD affects 4.5 million Americans. One in 10 persons over age 65 has AD, and nearly half of those over 85 have it. The levels of acetylcholine (ACh), a brain chemical involved in memory and thinking, decrease in people with AD. Aricept is believed to work by inhibiting the breakdown of ACh, thereby increasing available levels of this chemical in the brain.
Information About Aricept Treatment in Alzheimer's disease
While there is no cure for Alzheimer's disease, medical treatments are available to help manage symptoms of the disease. Once-a-day prescription Aricept is indicated for mild to moderate Alzheimer's disease.
In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with Aricept in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.
Aricept is well tolerated but may not be for everyone. Some people may have nausea, diarrhea, not sleep well or vomit. Some people may have muscle cramps, feel very tired or may not want to eat. In studies, these side effects were usually mild and went away over time. People at risk for stomach ulcers or who take certain other medicines should tell their doctors, because serious stomach problems, such as bleeding, may get worse. Some people who take Aricept may experience fainting.
Click here for more information on Aricept from the manufacturer.
Related Articles:
Aricept ODT Eisai Inc. - Treatment for Alzheimer’s Disease - October 18, 2004
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