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Schwarz Pharma announced today
that applications for marketing approval for the rotigotine
transdermal system, a patch, to treat patients in early stages
of Parkinson's disease have been submitted to both, the European
Medicines Agency (EMEA) and the U.S. Food and Drug Administration
(FDA).
Neupro, with the active ingredient rotigotine, is a novel dopamine
receptor-agonist formulated as a continuous transdermal delivery
system, a patch. The patch is applied once a day to the skin
and administers rotigotine transdermally 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.
More than 1,500 patients with Parkinson’s disease have
been treated with Neupro (rotigotine transdermal system) in
15 clinical trials.
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