Eisai and Pfizer have received approval from the FDA ( Food and Drug Administration ) for Aricept ( Donepezil ) 23 mg once daily tablet for the treatment of moderate-to-severe Alzheimer's disease.

The approval of Aricept 23 mg tablet is based on data from a large head-to-head study ( Study 326 ) of 1,467 patients with moderate-to-severe Alzheimer's disease, which showed that Donepezil 23 mg tablet demonstrated significant improvement in cognition compared to Donepezil 10 mg tablet.
Two co-primary endpoints were examined: the Severe Impairment Battery ( SIB ), which measures cognition, and the Clinician's Interview-Based Impression of Change Plus Caregiver Input ( CIBIC plus ), which measures global function.
While Donepezil 23 mg tablet, as compared to Donepezil 10 mg tablet, demonstrated a statistically significant improvement in SIB, it did not achieve statistically significant improvement in CIBIC plus. The changes in total score in the SIB was 2.6 in the 23 mg group compared to 0.4 in the 10 mg group, a difference of 2.2 ( p=0.0001 ), and the overall changes in score for the CIBIC plus was 4.23 in the Donepezil 23 mg tablet group compared to 4.29 in the 10 mg group, a difference of 0.06 ( p=0.1789 ).
The most frequently reported adverse events ( 5% or more ) with Donepezil 23 mg tablet were digestive symptoms such as nausea, vomiting, diarrhea and anorexia, which are commonly seen in patients taking acetylcholine esterase inhibitors.

Alzheimer's disease is a progressive, neurodegenerative disease that affects cognition. Age is the biggest risk factor for Alzheimer's disease, as the chances of developing the disease doubles every five years after age 65.

Aricept is an acetylcholine esterase inhibitor discovered and developed by Eisai and was approved first in the United States in November 1996. It increases levels of acetylcholine in the brain and slows disease progression by inhibiting acetylcholine esterase, an enzyme that breaks down the neurotransmitter acetylcholine.
Aricept is the first and only prescription medication approved in the United States by the FDA for the treatment of all stages of Alzheimer's disease-mild, moderate and severe dementia of the Alzheimer's type.

Source: Eisai, 2010

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