FDA approves new Alzheimer’s treatment
Drug slows decline in early Alzheimer’s
The Food and Drug Administration in Rockville, MD, recently granted marketing clearance for Exelon (rivastigmine tartrate) capsules, a cholinesterase inhibitor for the treatment of mild to moderate Alzheimer’s disease, manufactured by Novartis Pharmaceuticals in East Hanover, NJ.
Exelon therapy has proven effective in multiple phase III trials in the three key domains used to assess Alzheimer’s — activities of daily living, behavior, and cognition, according to George T. Grossberg, MD, director of the division of geriatric psychiatry at Saint Louis University School of Medicine.
"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," he says. "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 hope for Alzheimer’s patients and their caregivers."
In clinical trials, on average, patients treated with Exelon were considered clinically improved at the end of six months, compared with those receiving placebo. During the clinical trials, patients treated with 6 mg/day to 12 mg/day of Exelon were far more likely to experience substantial cognitive improvement and far less likely to show substantial decline than did the average placebo-treated patient.
Other findings from clinical trials include:
• At 26 weeks, 81% of patients given 6 mg/day to 12 mg/day of Exelon had greater improvement in, or less worsening of, cognitive function than did the average placebo-treated patient.
• Exelon patients demonstrated significant improvement compared with placebo patients in areas such as total word recall and recognition, orientation, and ability to speak.
• Patients given Exelon demonstrated fewer delusions and engaged in fewer purposeless activities than placebo patients.
• Higher therapeutic doses of Exelon were associated with greater benefit.
For more on Exelon, call (877) 439-3566 or visit the company’s Web site at www.novartis.com.
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