Eisai, Pfizer Gain Approval for Higher-Dose Aricept

Eisai and Pfizer received approval from the FDA for a new once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease (AD). Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD.

The approval is based on data from a large head-to-head study of Aricept 23 mg tablet versus Aricept 10 mg tablet in more than 1,400 patients with moderate-to-severe AD. Aricept 23 mg tablet demonstrated a statistically significant improvement in cognition, but did not achieve statistically significant improvement in global function, as compared to Aricept 10 mg tablet.