Schwarz Pharma's applications for marketing approval for Neupro (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 US 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. "This is an important milestone for our company. We are a step closer delivering on our strategy - to develop and to market innovative drugs in the areas of neurology and urology", said Patrick Schwarz-Schütte, CEO Schwarz Pharma AG.
Iris Loew-Friedrich, member of the executive board Schwarz Pharma AG stated, "The rotigotine team has worked diligently to bring the project to this significant achievement. With many advanced clinical development projects in our pipeline, we are looking forward to the NDA and MAA submissions to come."