 
New Alzheimer's Drug
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The Food and Drug Administration (FDA) has approved an Alzheimer's therapy that shows clinical benefits in all three key symptom areas: activities of daily living, global functioning (including behavior) and cognition. Eating and dressing, thinking and speaking -- these are the kind of tasks eased by Exelon (rivastigmine tartrate), a potent brain-selective cholinesterase inhibitor for the treatment of mild-to-moderate Alzheimer's disease (AD). The FDA's approval of Exelon is an important milestone for manufacturer Novartis Pharmaceuticals Corp. and for Alzheimer's patients and their families in the United States.
George T. Grossberg, M.D., Samuel W. Fordyce Professor and director of the division of geriatric psychiatry at the School of Medicine, served on the international safety monitoring board for Exelon and has been working with the compound since 1995.
"When an Alzheimer's patient declines in any one of the three domains of the disease, it has a major impact on the lives of patients and their caregivers," Grossberg said. "Early diagnosis and treatment are extremely important. A new therapy such as Exelon, which can affect symptoms early in the disease and is proven effective in all three critical domains of the illness, provides new hope for Alzheimer's patients and their caregivers."
The U.S. approval is based on data from more than 3,900 patients worldwide, the largest phase-III clinical program ever conducted with a medication for dementia of the AD type. During international trials, patients with mild- to moderately severe AD were treated with Exelon and showed significant benefit on virtually all activities of daily living (such as eating, dressing and completing household chores) compared with the placebo.
Patients taking Exelon also showed improved behavioral symptoms (such as fewer delusions and agitation). In a separate U.S. study with Exelon in nursing home patients, use of psychotropic medications was reduced. In addition, patients treated with Exelon were more likely to experience cognitive improvements (such as thinking, memory and speaking) compared with the placebo. In clinical studies published to date, Exelon shows the greatest benefit in cognition compared with the placebo.
Exelon is well tolerated and has a low potential for drug-drug interactions, particularly important since the average AD patient often takes many medications simultaneously.
The most common side effects are gastro-intestinal in nature; they are generally mild to moderate in intensity, transient and occur mainly during titration.
Alzheimer's disease is a progressive, neurodegenerative disease, affecting more than 10 million people worldwide and 4 million in the United States. It causes impaired memory, thinking and behavior.
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