FDA Allows Higher Dosage of Aricept for Alzheimer’s

The Food and Drug Administration (FDA) has announced the approval of a higher dosage of prescription Aricept, co-marketed by Eisai and Pfizer in the United States, to treat Alzheimer’s-related dementia.

The FDA approval follows the conclusion of a 1,400 patient study comparing 10 mg Aricept with 23 mg Aricept. The lengthy study tracked subjects with moderate or severe dementia. Two different testing methods were used; the Severe Impairment Battery (SIB) which validates cognitive function, and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) which tracks global functioning. The 23 mg version of Aricept had significant improvement in cognitive functioning, but did not provide a statistical improvement in global functioning. Relatively minor side effects were noted, including diarrhea, nausea, and vomiting.

Aricept, also known as donepezil, has been the first and thus far only medication approved by the FDA to treat mild, moderate, and severe dementia related to Alzheimer’s. While there is currently no cure for Alzheimer’s yet, Aricept may slow the course of the disease or stabilize the patient. The new 23 mg version of Aricept is believed to be scheduled for market release in August. Three years of exclusive sales are expected for the 23 mg Aricept.