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Neuproģ Re-Approved by FDA for Treatment of Parkinson's Disease
- Apr 03 2012
The Parkinson's Disease Foundation (PDF) alerts the community that rotigotine transdermal system (Neupro®) has been approved by the United States Food and Drug Administration (FDA) for the treatment of early and advanced stage Parkinson's disease.
Neupro is a dopamine agonist, novel because of its continuous drug delivery in the form of a skin patch. Neupro was first approved as a treatment for early stage Parkinson's in 2007. In 2008, the product was recalled from the market because of a manufacturing issue that caused the medication to crystallize.
The crystallization did not cause toxic effects, but reduced the amount of the medication that was available to be absorbed through the skin, lowering its efficacy.
The manufacturer, noting the problem was caused by distribution and storage, worked to correct it.
The manufacturer states that Neupro will be available in US pharmacies in July 2012.
Dr. Christopher Goetz, Chair of the Parkinson's Disease Foundation (PDF) Medical Policy Committee and member of PDF's Scientific Advisory Board comments, "Rotigotine studies established its utility and the unfortunate manufacturing problem now appears to be resolved. Having rotigotine patch available again will be very positive and will offer physicians a new option for their day to day management of patients with Parkinson’s disease. It is the only available treatment in the form of a 24 hour patch for our patients with Parkinson’s disease."
Would you like more information on medication for Parkinson's? Join us online or by phone on Tuesday, April 17 for a PD ExpertBriefing entitled, "Parkinson's Medications: Today or Tomorrow," led by Cynthia L. Comella, M.D., F.A.A.N., of Rush University Medical Center.
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Source Date: Apr 03 2012