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New FDA-approved dosing option for treating moderate-to-severe Alzheimer's disease

| September 19, 2010 2:00 PM

(ARA) - According to the Alzheimer's Association, about 3.6 million Americans age 65 and older have moderate-to-severe Alzheimer's disease (AD), which is a degenerative disease of the brain that gets worse over time. By 2050, this number is expected to nearly triple to 10.4 million.

With the growing aging population, it is important to develop treatments that may help patients and their families living with this devastating condition. The U.S. Food and Drug Administration (FDA) recently approved a new once-daily, higher dose Aricept (R)(donepezil HCl) 23 mg tablet, offering a new dosing option for patients with moderate-to-severe AD. In the study of patients with moderate-to-severe AD, cognition was significantly improved in patients taking the Aricept 23 mg tablet versus those taking the Aricept 10 mg tablet, whereas global functioning was not.

"Slowing the decline of cognitive symptoms is important at all stages of Alzheimer's disease," said Dr. Martin R. Farlow, lead author of the study publication and professor and vice-chairman of research in Indiana University School of Medicine's Department of Neurology. "Throughout the course of Alzheimer's disease, caregivers are usually the first to notice changes in cognition. When a loved one notices the disease has gotten worse, it is important that they speak with a doctor about these changes and consider other treatments."

About Alzheimer's disease

Age is the biggest risk factor for AD, as the chances of developing the disease doubles every five years after age 65. AD affects the patient, caregivers and the entire family. In fact, nearly 11 million people in the United States - mostly women - take care of a loved one with AD in addition to their families. Family members can create a support system for their loved ones by engaging with healthcare professionals and AD groups as early as possible.

About Aricept (donepezil HCl)

Aricept is the first and only prescription medication approved by the FDA for the treatment of all stages of AD - mild, moderate and severe dementia of the Alzheimer's type. It is not a cure for AD, but Aricept may help provide symptomatic benefit for some patients. Aricept may work differently for each person. For those who respond, symptoms may improve, they may stabilize or they may progress more slowly than without Aricept. Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

Aricept is a prescription medicine to treat mild Alzheimer's disease (5 mg or 10 mg) and moderate to severe Alzheimer's disease (10 mg or 23 mg).

Before starting on ARICEPT 23 mg/day, patients should be on ARICEPT 10 mg/day for at least three months. The starting dose of ARICEPT is 5 mg/day and can be increased to 10 mg/day after four to six weeks. Please take ARICEPT as prescribed by the doctor.

Important safety information

ARICEPT may not be for everyone. 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.

People at risk for certain heart conditions should tell their doctor before starting ARICEPT because they may experience fainting. People with serious lung conditions and difficulty breathing, bladder problems or seizures should tell their doctor before using ARICEPT. ARICEPT 23 mg is associated with weight loss. Check with the doctor if this is a concern. Inform the doctor if the patient needs surgery requiring anesthesia while taking ARICEPT.

Some people may have nausea, diarrhea, difficulty sleeping, vomiting or muscle cramps. Incidence of nausea and vomiting were markedly greater in patients taking ARICEPT 23 mg/day versus patients taking ARICEPT 10 mg/day. Some people may feel tired or may have loss of appetite. If they persist, please talk to the doctor.

For Full Prescribing and Patient Information, please visit www.aricept.com.

Disclosure

This article was provided by Eisai Inc. and Pfizer Inc.

Dr. Farlow serves as a consultant to Eisai Inc. and Pfizer Inc.