The Neupro patch (rotigotine transdermal system) has been approved by the US Food and Drug Administration (FDA) as the first skin patch to treat symptoms of early Parkinson's disease.
The active drug, rotigotine, hadn't been approved previously in the United States. It is a member of the dopamine agonist class of drugs, which activates body processes that mimic the effects of the neurotransmitter dopamine. Parkinson's is caused by a loss of dopamine-producing brain cells.
During clinical testing involving more than 1,100 people, side effects for the Neupro patch included skin reactions, dizziness, nausea, vomiting, drowsiness and insomnia. The FDA cited other potential safety concerns" including the possibility of falling asleep while driving and a sudden drop in blood pressure upon standing up.
The agency cited statistics from the Parkinson's Action Network that revealed that more than 1 million Americans live with the disease and 60,000 new cases are diagnosed annually. Symptoms include trembling of the arms, legs, jaw and face; impaired balance; and stiffness of the limbs and trunk.
The Neupro patch is produced by Schwarz Bioscience of Research Triangle Park, North Carolina.
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