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news.Schwarz Pharma has re-submitted a revised new drug application for its rotigotine patch, Neupro, for the treatment of Parkinson's disease to the FDA. The FDA had not accepted the first application form due to electronic issues.
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Electronic applications for the rotigotine patch were submitted to both the FDA and the European Medicines Evaluation Agency (EMEA) on September 29, 2004. While the application form was accepted by the EMEA, the FDA refused to accept the form due to electronic issues.
“Schwarz Pharma worked closely with FDA to address their concerns with the electronic formatting of the new drug application (NDA),” commented Dr Iris Loew-Friedrich, member of the executive board of Schwarz Pharma AG responsible for R&D. “We believe we have resolved all of the issues in the re-submission.”
The rotigotine patch is an innovative approach combining the advantages of a non-ergolinic dopamine agonist acting on D3/D2 receptors, with transdermal delivery over 24 hours. It features a once daily application and is replaced every 24 hours. Unlike oral medications, the patch has the potential to deliver a dopamine agonist continuously, which may result in the reduction of symptoms associated with Parkinson’s disease.