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Namenda (Memantine) Shows Benefit in Behavioral Disturbances Associated With Moderate to Severe Alzheimer's Disease: Presented at AAGP

BALTIMORE, MD -- February 24, 2004 -- Forest Laboratories, Inc. (NYSE: FRX) announced today the presentation of new data on behavioral outcomes from the first clinical trial evaluating the treatment of patients with moderate to severe Alzheimer's disease with a combination of two available Alzheimer's drugs: Namenda(TM) (memantine HCl) and donepezil.

The results from the behavioral analysis demonstrate that treatment with Namenda and donepezil is associated with improvement in behaviors such as agitation, irritability and appetite changes in patients with moderate to severe Alzheimer's disease compared to baseline, while patients treated with donepezil and placebo declined relative to their baseline status. The study's new in-depth behavioral analysis was presented today at the American Association for Geriatric Psychiatry (AAGP) Annual Meeting in Baltimore, Maryland. Preliminary results of the study findings were recently reported in the Journal of the American Medical Association.

"The behavioral problems that are generally seen in the later stages of Alzheimer's disease ranging from aggression to sleep disturbances can dramatically increase caregiver burden and often lead to placing patients in nursing homes," said Jeffrey L. Cummings, M.D., August Rose Professor of Neurology and Professor of Psychiatry and Biobehavioral Sciences at the David Geffen School of Medicine, University of California, Los Angeles. "Namenda diminished behavioral symptoms of Alzheimer's disease in this study, and this may ease caregiver burden and potentially keep a patient at home with his or her family longer."

Namenda, now available in the United States, is the first and only therapy approved to treat the moderate to severe stages of Alzheimer's disease. Namenda has a unique mechanism of action and it has been demonstrated to be safe and effective when administered as monotherapy or in combination with donepezil. All other approved treatments, including donepezil, belong to a class of drugs called acetylcholinesterase inhibitors (AChEI) and are indicated only for patients in the mild to moderate stages of Alzheimer's.

Namenda Shown to Help Reduce Behavioral Disturbances in Alzheimer's Patients

Data demonstrate that patients receiving the combination of Namenda and donepezil experienced an overall reduction in behavioral disturbances and psychiatric symptoms relative to baseline, while patients treated with donepezil alone experienced an increase or worsening of these symptoms. The frequency and severity of behavioral disturbances were evaluated in aggregate with the Neuropsychiatric Inventory (NPI), a standard assessment scale that measures a range of common behavioral symptoms often associated with Alzheimer's patients. The difference between the two groups in the change from baseline at the six-month endpoint on the NPI in this trial was statistically significant (p=0.002). Several individual behaviors that showed statistically significant improvement compared to baseline in patients treated with Namenda compared to placebo treatment included: agitation/aggression (p=0.001), irritability/lability (p=0.005) and appetite/eating change (p=0.045).

In general, the incidence of treatment-emergent adverse events was similar in patients treated with Namenda/donepezil and the placebo/donepezil combination. A significantly greater percentage of patients in the Namenda/donepezil group (85 percent vs. 75 percent) completed the study compared to the placebo/donepezil group (p=0.011).

The results of this analysis expand upon the data from this landmark study published earlier this year in The Journal of the American Medical Association (Vol 291, No. 3) that demonstrated that patients with moderate to severe Alzheimer's disease taking a combination of Namenda and donepezil experienced significant positive cognitive, functional, and global benefits compared to patients treated with donepezil alone.

Study Design

The in-depth behavioral data presented today were derived from the first study designed to evaluate the safety and efficacy of treating moderate to severe Alzheimer's disease patients with a combination of Namenda and donepezil. The six-month study included 404 patients at 37 sites and was a prospectively designed, double-blind, placebo-controlled, Phase III trial. Study patients were required to receive a stable dose of donepezil for at least three months; all patients were treated with donepezil for a minimum of six months. Patients were then randomized to receive donepezil plus 10 mg of Namenda twice a day, or donepezil and placebo.

Behavioral Problems and Alzheimer's Disease

Alzheimer's disease can cause a person to exhibit marked behavioral changes that are difficult for caregivers to manage. These symptoms can include withdrawal, apathy, depression, hostility, anger, and aggression, with most patients exhibiting some or all of these symptoms during the course of the disease. As the disease progresses, behavioral symptoms often increase in frequency and severity. Managing a patient's behavioral symptoms is an important component of treatment regimens for Alzheimer's disease.

About Namenda

Namenda (memantine HCl) is the first in a new class of medications with a unique mechanism of action that focuses on the glutamate pathway, a new target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe Alzheimer's disease, Namenda was recently approved by the FDA based on the results of three placebo-controlled studies which demonstrated Namenda's efficacy as monotherapy, or when used in combination with the commonly prescribed drug, donepezil. Results from the two U.S. studies in moderate to severe Alzheimer's disease have been published in The New England Journal of Medicine and The Journal of the American Medical Association.

* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.


SOURCE: Forest Laboratories, Inc.

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