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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P07-84
May 9, 2007

Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Approves Neupro Patch for Treatment of Early Parkinson's Disease

The U.S. Food and Drug Administration (FDA) today announced the approval of Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease.

Rotigotine is a drug not previously approved in the United States. Neupro is the first transdermal patch approved for the treatment of symptoms of Parkinson's disease.

Parkinson's disease, which belongs to a group of conditions called motor system disorders, results from the loss of dopamine-producing brain cells. Rotigotine, a member of the dopamine agonist class of drugs, is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptors in the body, mimicking the effect of the neurotransmitter dopamine.

The effectiveness of Neupro was demonstrated in one fixed-dose response study and two flexible-dose studies. The parallel group studies were randomized, double-blinded, and placebo-controlled, and involved 1,154 patients with early Parkinson's disease who were not taking other Parkinson's medications.

The most common side effects for Neupro included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness and insomnia, most of which are typical of this class of drugs. Other potential safety concerns include sudden onset of sleep while engaged in routine activities such as driving or operating machinery (sleep attacks), hallucinations, and decreased blood pressure on standing up (postural hypotension).

Neupro Patch is manufactured by Schwarz Bioscience of Research Triangle Park, N.C.

According to the Parkinson's Action Network, more than 1 million Americans live with Parkinson's disease and 60,000 new cases are diagnosed each year. The four primary symptoms of Parkinson's are trembling in hands, arms, legs, jaw, and face (tremor); stiffness of the limbs and trunk (rigidity); slowness of movement (bradykinesia,); and impaired balance and coordination (postural instability). As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing other simple tasks.

For more information
National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm

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