WEDNESDAY, June 28 (HealthDay News) -- Exelon (rivastigmine tartrate) was approved June 27 by the U.S. Food and Drug Administration as the first treatment for mild to moderate dementia in Parkinson disease. The FDA had previously approved the drug for the treatment of mild to moderate dementia in Alzheimer disease.
The new approval is based on a randomized, placebo-controlled study of 541 Parkinson disease patients who showed dementia symptoms two or more years after diagnosis. The 24-week study showed that the Exelon group had better scores on mental-process tests than the placebo group.
Clinical trials show that Exelon is associated with adverse gastrointestinal effects, including nausea (47 percent of patients), vomiting and dyspepsia. High doses have been associated with weight loss in 26 percent of women and 18 percent of men. Some Parkinson disease patients also have experienced worsening of tremor.
"It's been recognized for almost a decade that the dementia of patients with Parkinson disease differs from the dementia of patients with Alzheimer's," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "But until now, there has been no treatment that has been shown to be effective specifically for the dementia associated with Parkinson disease. Today's approval of Exelon helps to fill this medical need."
Exelon is manufactured by Novartis Pharmaceutical Corp. in East Hanover, N.J.
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