THURSDAY, May 10, 2007 (HealthDay News) -- The Neupro patch (rotigotine transdermal system) has been approved by the U.S. Food and Drug Administration as the first skin patch to treat symptoms of early Parkinson's disease, the agency said Wednesday.
The active drug, rotigotine, hadn't been previously approved in the United States. It's 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 once-daily Neuro 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 on standing up.
The agency cited Parkinson's Action Network statistics 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 Neuro patch is produced by Schwarz Bioscience of Research Triangle Park, N.C.
The FDA has more about this approval.