By Bob DeMarco Alzheimer’s Reading Room Eisai Inc. and Pfizer Inc [NYSE: PFE] announced today that the U.S. Food and Drug Administration (FDA) approved 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, for whom few treatments are available. Eisai Inc. and Pfizer Inc [NYSE: PFE] announced today that the U.S. Food and Drug Administration (FDA) approved 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, for whom few treatments are available. According to the Alzheimer’s Association, approximately 3.6 million Americans age 65 and older have moderate-to-severe AD. “Slowing the decline of cognitive symptoms is important at all stages of Alzheimer’s disease,” said Dr. Martin R. Farlow, professor and vice-chairman of research, department of neurology, Indiana University School of Medicine and lead author of the pivotal study publication. “Throughout the course of AD, caregivers are usually the first to notice changes in cognition. It’s important for families to talk with their doctor when they notice a worsening in cognitive function in their loved ones to reevaluate therapeutic needs.” Based on the approved label, the recommended starting dose of Aricept is 5 mg once daily and can be increased to Aricept 10 mg once daily after four-to-six weeks. Moderate-to-severe AD patients who are established on a regimen of Aricept 10 mg tablet for at least three months are candidates for dose escalation to Aricept 23 mg tablet. Nausea, vomiting, diarrhea and anorexia were the most common adverse events noted in the pivotal study of Aricept 23 mg tablet. “We have a long-standing commitment to the AD community and recognize that there are few treatment options available,” said Lonnel Coats, president and CEO, Eisai Inc. “In drawing upon our heritage, we are proud to offer a new dosing option to caregivers and patients living with this debilitating condition.” AD is a progressive, neurodegenerative disease.

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