Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD). This new higher dose formulation contains 23 mg of donepezil HCl in an extended release, matrix-type tablet with a delivery system that allows for gradual release of the drug. The NDA is based on a head-to-head clinical study comparing the 23 mg Aricept extended release tablet to the currently marketed once daily 10 mg Aricept® (donepezil HCl) immediate release tablet. More than 1400 patients with moderate to severe Alzheimer's disease were enrolled in this global study.
Acceptance of the NDA indicates that the FDA has found the company's submission to be sufficiently complete to review. Eisai and Pfizer believe this new formulation will potentially provide physicians, patients and their families with another option for the management of Alzheimer's disease.
Cosmochemistry techniques shed light on potential new Alzheimer's disease biomarker