Posted by ed_uk on February 25, 2006, at 18:19:42
February 20, 2006
Neupro® Approved in Europe for the Treatment of Early Parkinson's Disease
SCHWARZ PHARMA will be able to launch the Parkinson's patch in the first European markets within the next weeks.
SCHWARZ PHARMA announced today that the European Medicines Agency (EMEA) has given marketing authorization for Neupro® (rotigotine transdermal patch), for the treatment of Parkinson's disease as monotherapy. In December 2005, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA had already adopted a positive opinion recommending marketing authorization for Neupro®. SCHWARZ PHARMA will now be able to market Neupro® throughout all 25 European Union countries as well as Iceland, Liechtenstein and Norway.
"This is a historic moment for our company. With the Parkinson’s patch Neupro, the first drug from our innovative development pipeline will come to the market,” said Patrick Schwarz-Schuette, CEO SCHWARZ PHARMA AG. "We will start with the market introduction in Germany and the United Kingdom within the next weeks."
Neupro®, with the active ingredient rotigotine, is a non-ergoline dopamine receptor-agonist formulated as a transdermal delivery system, a patch. The patch is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Multinational clinical studies with patients in early stages of Parkinson's disease were completed at the end of 2003. In 15 clinical trials, more than 1,500 patients with Parkinson’s disease have been treated with rotigotine transdermal patch. The clinical trials have shown efficacy and safety in early Parkinson's disease patients and a potential for long term benefit. Rotigotine exhibits a promising receptor profile, rapid metabolism and low potential of pharmacokinetic drug-drug interactions. The patch administration of rotigotine offers the convenience of once daily-dosing and easy usage.
Results of a rotigotine phase III study conducted in Europe, published in December 2005, show that rotigotine transdermal patch is also effective in treating patients with advanced Parkinson’s disease. This outcome confirms favorable results already obtained from a phase III study conducted in the USA at the end of 2004. SCHWARZ PHARMA plans to submit marketing applications at the end of 2006.
SCHWARZ PHARMA is also developing a rotigotine patch for treating Restless Legs Syndrome. The double-blind and placebo-controlled phase III trial program started in May 2005; first results are expected in the first quarter of 2007.
Parkinson’s disease is a disorder of the central nervous system. The patients - roughly four million worldwide - suffer from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists attempt to compensate for this lack of dopamine.
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