(BUSINESS WIRE)--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.

The approval of Aricept 23 mg tablet is based on data from a large head-to-head study of Aricept 23 mg tablet versus Aricept 10 mg tablet in over 1,400 patients with moderate-to-severe AD.

Two co-primary endpoints were examined: the Severe Impairment Battery (SIB), a validated clinical instrument that measures cognition, and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+), another validated clinical instrument that measures global function. 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.

“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 Alzheimer’s disease, 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. Age is the biggest risk factor for AD, as the chances of developing the disease double every five years after age 65. According to the Alzheimer’s Association, by 2050, it is estimated 13.5 million Americans may have AD, and 77 percent ­– or 10.4 million – of them may have moderate or severe disease.

“With the growing aging population and the increasing burden of Alzheimer’s disease on patients and their families, it is more important than ever to develop valuable therapies for the treatment of the disease,” said Adele M. Gulfo, president and general manager, U.S. Primary Care Business Unit at Pfizer. “The approval of Aricept 23 mg tablet demonstrates our ongoing commitment to delivering treatment options that may help patients and their families living with Alzheimer’s disease.”

Study Details

The head-to-head, double-blind, placebo-controlled, parallel-group clinical study randomized 1,467 patients with moderate-to-severe AD who had been treated for three months or more with Aricept 10 mg tablet. In the study, patients who received the increased dose of Aricept 23 mg tablet once daily were compared to patients who continued on with the Aricept 10 mg tablet once daily to determine if the Aricept 23 mg tablet could offer incremental benefit in cognition (SIB) and global function (CIBIC+).

The study’s two primary endpoints were the SIB and the CIBIC+. The change in total scores from baseline to week 24 on the SIB was 2.6 points in the Aricept 23 mg tablet group compared to 0.4 points in the Aricept 10 mg tablet group, resulting in a treatment difference that was statistically significant. This was based on the data from the intent-to-treat (ITT) population (ITT was 1,371 patients, p = 0.0001), with similar results for an analysis using data from the observed cases (1,084 patients who finished the study).

For the CIBIC+, the overall change score at week 24 was 4.23 in the Aricept 23 mg tablet group compared to 4.29 in the 10 mg tablet group (ITT, p = 0.1789), but this difference was not statistically significant.

In the pivotal trial, the most common adverse events (greater than or equal to 5 percent and greater than the 10 mg tablet group) with Aricept 23 mg tablet versus Aricept 10 mg tablet, respectively, were nausea (11.8 percent vs. 3.4 percent), vomiting (9.2 percent vs. 2.5 percent), diarrhea (8.3 percent vs. 5.3 percent) and anorexia (5.3 percent vs. 1.7 percent).

About Aricept (donepezil HCl)

Aricept is the first and only prescription medication approved by the FDA for the treatment of all stages of AD—mild, moderate and severe dementia of the Alzheimer's type. It is not a cure for AD, but Aricept may help provide symptomatic benefits for some patients. Aricept may work differently for each person. For those who respond, symp­toms may improve, they may stabilize or they may progress more slowly than without Aricept. Aricept is currently available in 5 mg tablet, 10 mg tablet, orally disintegrating tablet (5 mg and 10 mg) and now 23 mg tablet. The Aricept 23 mg tablet is expected to be available in U.S. pharmacies in August. Based upon the submission of the Aricept 23 mg tablet clinical trial data to the FDA, Aricept 23 mg tablet is expected to have three years of data exclusivity in the United States. Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

IMPORTANT SAFETY INFORMATION

ARICEPT may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse.

People at risk for certain heart conditions should tell their doctor before starting ARICEPT because they may experience fainting. People with serious lung conditions and difficulty breathing, bladder problems or seizures should tell their doctor before using ARICEPT. ARICEPT 23 mg is associated with weight loss. Check with the doctor if this is a concern. Inform the doctor if the patient needs surgery requiring anesthesia while taking ARICEPT.

Some people may have nausea, diarrhea, difficulty sleeping, vomiting or muscle cramps. Incidence of nausea and vomiting were markedly greater in patients taking ARICEPT 23 mg/day versus patients taking ARICEPT 10 mg/day. Some people may feel tired or may have loss of appetite. If they persist, please talk to the doctor.

For Full Prescribing and Patient Information, please visit www.eisai.com.

Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.

Pfizer Inc: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.