FDA Approves the First Treatment for Dementia of Parkinson's Disease
The Food and Drug Administration (FDA) today approved Exelon (rivastigmine tartrate) for the treatment of mild to moderate dementia (chronic loss or impairment of intellectual capacity) associated with Parkinson's disease, a disorder of the central nervous system. Exelon was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type.
"It's been recognized for almost a decade that the dementia of patients with Parkinson's disease differs from the dementia of patients with Alzheimer's," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, "but until now, there has been no treatment that has been shown to be effective specifically for the dementia associated with Parkinson's Disease. Today's approval of Exelon helps to fill this medical need."
It is estimated that about 0.2 percent to 0.5 percent of people over 65 years of age are affected by Parkinson's dementia and experience such symptoms as impairments in executive function, memory and attention. The approval of Exelon for the treatment of Parkinson's dementia is based on the results of a randomized, placebo-controlled clinical study with 541 patients who showed symptoms of mild to moderate dementia two years or later after their diagnosis for Parkinson's disease. At the end of the 24-week trial, the condition of the Exelon-treated patients, as shown on a scale that measures mental processes, was significantly better than the condition of the patients on placebo.
The use of Exelon has been associated with significant gastrointestinal adverse reactions. In clinical trials, 47 percent of the patients treated with the drug developed nausea, and 26 percent of women and 18 percent of men on high doses of Exelon experienced significant weight loss. Other common adverse events reported by patients on Exelon include vomiting, anorexia, dyspepsia and asthenia (loss of strength). In some patients with Parkinson's disease, treatment with Exelon was associated with a worsening of tremor.
Exelon is manufactured by Novartis Pharmaceutical Corp. in East Hanover, NY.
Posted: June 2006