MONHEIM, Germany (AFX) - Schwarz Pharma AG said a second phase III trial of its rotigotine patch for severe restless legs syndrome (RLS) has produced 'relevant and statistically significant' reduction of symptoms.
Schwarz Pharma also said it will apply for regulatory approval for the drug by the fourth quarter.
'We have seen another promising set of results underlying the efficacy and safety of rotigotine in Restless Legs Syndrome,' company board member Iris Loew-Friedrich said in a statement.
'This trial has the potential to be considered as the second pivotal trial and it replicates the results of the clinical program in RLS that have been reported thus far. We are now preparing the application documents for a regulatory submission by the fourth quarter of 2007.' alfred.kueppers@afxnews.com amk/jfr COPYRIGHT Copyright AFX News Limited 2006. All rights reserved. The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News. AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited