First New Parkinson's Drug This Decade Cleared In U.S.
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First New Parkinson's Drug This Decade Cleared In U.S.

KALAMAZOO, Mich., July 3, 1997 -- The United States Food and Drug Administration (FDA) today has given Pharmacia & Upjohn Company marketing clearance for the prescription sale of Mirapex Tablets (pramipexole dihydrochloride tablets), a new drug to treat Parkinson's disease. Mirapex is the first new Parkinson's drug cleared by the FDA since 1989.

Mirapex is in the dopamine agonist drug class. A comprehensive clinical trial program showed that the drug can be used to treat patients who have idiopathic Parkinson's disease in early and advanced stages of the disease.

Mirapex can be used without levodopa for treatment of early disease and with levodopa to treat advanced stages of Parkinson's disease to help improve patients' motor performance and activities of daily living. Levodopa is currently the medication most often used to treat advanced Parkinson's disease.

The most common side effects of Mirapex are generally similar to other dopamine agonists. The most frequently reported side effects of patients in early Parkinson's disease who were treated with Mirapex were nausea, dizziness, drowsiness and insomnia. The most common side effects reported by patients in advanced stages of Parkinson's who were treated with Mirapex and levodopa, were postural hypotension, dyskinesias, extrapyramidal syndrome, insomnia, dizziness and hallucinations.

All Parkinson's patients should be informed that postural hypotension may occur more frequently during initial treatment, and hallucinations can occur at any time during the course of treatment.

Parkinson’s disease

Parkinson's disease is an illness that causes the depletion of dopamine-producing neurons in the brain. These neurons help the body to function normally. The loss of dopamine causes physical symptoms such as rigidity, tremors, slowed movement, a shuffled walk and postural instability. Mirapex is believed to work by targeting dopamine receptors in the brain, binding to these receptors, and stimulating them, thus enhancing motor skill function.

Mirapex will be co-marketed in the United States by Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceuticals, Inc. The two companies plan to begin distribution of Mirapex to pharmacies across the United States by July 10.

More information on: Pharmacia & Upjohn, Boehringer Ingelheim Pharmaceuticals, Inc.

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