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I just got this much awaited good news from my local Pharmacia & Upjohn rep. The bottom line is that the drug has now been approved with a few minor changes. The drug company representatives will have samples available at the end of next week and will be making the rounds of the PD specialists. It may take a couple of weeks for the drug to reach pharmacies around the country. My drug rep contact suggests that you can speed this up by going into your local pharmacy and telling them that your physican has ordered Mirapex (pramipexole) for you. This may get the drug to your local pharmacy quicker. Carole > > > 2 July 1997 > > New Parkinson's Drug Receives Marketing Clearance > > The following was released to the media. > > Mirapex is the first new Parkinson's drug cleared in the United States >this > decade > > (KALAMAZOO, Mich.) -- The United States Food and Drug Administration > (FDA) today has given Pharmacia & Upjohn 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 > will be co-marketed in the United States by P&U and Boehringer > Ingelheim Pharmaceuticals, Inc. The two companies have worked together > since 1991 on the development of the drug synthesized by Boehringer > Ingelheim. > > 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. > > "Mirapex will provide another option for Parkinson's patients to > improve their daily living functions," said Mark Corrigan, M.D., > Ph.D., vice president of CNS development for Pharmacia & Upjohn. > "Mirapex can be used with other Parkinson's medications, an important > fact because the average patient requires multiple medications." > > 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 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. > > "For many years, Boehringer Ingelheim has had a very active research > program in central nervous system diseases such as Parkinson's > disease, stroke, depression and Alzheimer's disease," said Doug > Wilson, M.D., Ph.D., senior vice president of Medical Affairs/DRA, > Boehringer Ingelheim Pharmaceuticals, Inc. "Mirapex represents the > first drug to emerge from this program." > > Pharmacia & Upjohn and Boehringer Ingelheim Pharmaceuticals, Inc. plan > to begin distribution of Mirapex to pharmacies across the United > States by 10 July. The two companies expect to reach 100 percent > distribution by 31 July. > > The New Drug Application (NDA) for Mirapex was submitted to the FDA > on 28 December 1995. Boehringer Ingelheim began research on Mirapex > in healthy volunteers in January 1988. Pharmacia & Upjohn joined the > research in 1991 beginning with phase III studies. > > Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., > is the largest U.S. subsidiary of Boehringer Ingelheim Corporation > (Ridgefield, Conn.). Boehringer Ingleheim Corporation is a member of > the Boehringer Ingelheim worldwide group of companies headquartered in > Ingelheim, Germany. A privately held company, founded in 1885, > Boehringer Ingelheim is a major pharmaceutical, chemical, animal > health, and bakery products manufacturer with operations in more than > 100 countries around the world. > > Corporate Communications > > Remove from boards: 7/16/97 > Distribution: Worldwide > >