FDA OKs Dopamine Agonist Patch for Parkinson Disease
More serious potential side effects include sleep attacks, hallucinations and postural hypotension
THURSDAY, May 10 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first transdermal patch to treat the symptoms of Parkinson disease. The Neupro Patch, manufactured by Schwarz Bioscience of Research Triangle Park, N.C., contains the dopamine agonist rotigotine, previously not approved in the United States.
The FDA granted approval based on data from three randomized, double-blind, placebo-controlled studies involving 1,154 patients with early Parkinson disease. One study looked at the response to a fixed dose and the other two were flexible-dose studies.
Rotigotine activates the body's dopamine receptors, thus mimicking the neurotransmitter effect of dopamine. Side effects observed in the studies include skin irritation at the site of the patch, nausea, dizziness and vomiting. More serious potential side effects include sleep attacks, hallucinations and postural hypotension. The patch is silicone-based and is effective for 24 hours.