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FDA Approves Higher-Dose Aricept for Alzheimer's Disease


The US Food and Drug Administration has approved a new once-daily, higher-dose Aricept (donepezil HCl) 23 milligram table for the treatment of moderate-to-severe Alzheimer’s Disease. The drug is marketed by Eisai Inc of Japan and Pfizer Inc.

The approval of the Aricept 23 mg tablet is based on data from a study involving over 1400 patients with moderate-to-severe Alzheimer’s disease. Based on the results of two exams – the Severe Impairment Battery (SIB), which measures cognition, and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+), which measures global function – those who took Aricept 23 mg demonstrated a statistically significant improvement in cognition as compared to Aricept 10 mg.

However, there was not an associated improvement in global function.

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“Slowing the decline of cognitive symptoms is important at all stages of Alzheimer’s disease,” said Dr. Martin R. Farlow, professor and vice-chairman of research, department of neurology, Indiana University School of Medicine and lead author of the study. “Throughout the course of AD, caregivers are usually the first to notice changes in cognition. It’s important for families to talk with their doctor when they notice a worsening in cognitive function in their loved ones to reevaluate therapeutic needs.”

Alzheimer’s disease is a progressive, neurodegenerative disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities. It affects about 5.3 million Americans, according to the Alzheimer’s Association.

Aricept does not cure the disease, but helps to ease the symptoms. Aricept is in a class of medications called cholinesterase inhibitors which helps improve mental function by increasing the amount of a certain naturally occurring substance in the brain.

Based on the approved label, the recommended starting dose of Aricept is 5 mg once daily and can be increased to Aricept 10 mg once daily after four-to-six weeks. Moderate-to-severe AD patients who are established on a regimen of Aricept 10 mg tablet for at least three months are candidates for dose escalation to Aricept 23 mg tablet.

Nausea, vomiting, diarrhea and anorexia were the most common adverse events noted in the pivotal study of Aricept 23 mg tablet. Other side effects may include frequent urination, muscle cramps, joint pain, fatigue, depression, confusion, or insomnia.