Novartis given FDA approval of Exelon for Parkinson's disease

New York, June 27 - Novartis Pharmaceutical Corp. won approval from the Food and Drug Administration of Exelon (rivastigmine tartrate) for the treatment of mild to moderate dementia (chronic loss or impairment of intellectual capacity) associated with Parkinson's disease, the FDA said.

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 Steven Galson, director of the FDA's center for drug evaluation and research, in a news release, "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."

The FDA said it is estimated that 0.2% to 0.5% of people over 65 are affected by Parkinson's dementia and experience symptoms such as impairments in executive function, memory and attention.

Approval of Exelon was 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 a placebo.

The use of Exelon has been associated with significant gastrointestinal adverse reactions, the FDA said. In clinical trials, 47% of the patients treated with the drug developed nausea, and 26% of women and 18% 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.

Novartis Pharmaceutical is an East Hanover, N.Y., subsidiary of Basel, Switzerland-based pharmaceutical company Novartis.

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