The FDA has approved Eisai’s Aricept (donepezil HCl tablets) in a 23mg dosage strength for the treatment of moderate-to-severe Alzheimer’s disease. This approval was based on clinical data from a study conducted in 1,467 patients with moderate-to-severe Alzheimer’s disease. The study demonstrated that Aricept 23mg significantly improved cognition compared to Aricept 10mg as measured by the Severe Impairment Battery (SIB) assessment, which measures cognition. The changes in total score in the SIB (higher scores are better) was 2.6±0.58 in the 23mg group compared to 0.4±0.66 in the 10mg group, a difference of 2.2 (p=0.0001).

Aricept 23mg is expected to be available in August 2010. Aricept is already available in 5mg and 10mg dosage strength tablets. Aricept ODT (donepezil HCl orally-disintegrating tablets) is available in 5mg and 10mg dosage strengths.

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