FDA accepts NDA for extended release Aricept, a treatment for Alzheimer's disease (AD)Eisai and Pfizer announced that the FDA has accepted for review the 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.
Aricept is a reversible acetylcholinesterase inhibitor presently approved for the treatment of mild, moderate and severe dementia associated with AD. Aricept is currently available in 5 and 10mg tablets and 5 and 10 mg orally disintegrating tablets.For more information call (888) 422-4743 or visit www.aricept.com.