Positive Results with Rotigotine in Restless Legs Syndrome in Second Phase III Trial
First Results from the Second Phase III Trial with Rotigotine Transdermal Patch in Patients Suffering from Restless Legs Syndrome Show Clinically Relevant and Statistically Significant Reduction in Symptoms. Schwarz Pharma Plans for a Regulatory Submission by the Fourth Quarter of 2007.
Monheim, Germany, Jan. 11, 2007 - SCHWARZ PHARMA announced today that a second phase III trial with rotigotine transdermal patch for the treatment of the signs and symptoms of moderate to severe Restless Legs Syndrome (RLS) has shown a clinically relevant and statistically significant reduction of RLS symptoms versus placebo in both primary variables. Rotigotine was also well tolerated in this trial. In October 2006, SCHWARZ PHARMA had previously reported positive results for the first phase III trial with rotigotine in RLS.
Iris Loew-Friedrich, MD, PhD, Member of the Executive Board SCHWARZ PHARMA AG said: “We have seen another promising set of results underlying the efficacy and safety of rotigotine in Restless Legs Syndrome. 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."
505 patients with moderate to severe RLS were treated in this multi-center, double-blind, placebo-controlled phase III study. All patients began the four-week titration period at a daily dosage of 0.5 mg/24h rotigotine transdermal patch or placebo. During the six-month period of treatment, the patients received rotigotine transdermal patch (0.5, 1, 2 or 3 mg/24h) or placebo patch on a daily basis. Co-primary endpoints were the absolute change from baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) sum score and in the Clinical Global Impression (CGI) item 1 score (severity of illness) at the end of maintenance period.
Treatment with rotigotine at daily doses of 2 and 3 mg/24h led to a clinically relevant and statistically significant reduction in the IRLS sum score and in the CGI item 1 score compared to placebo. Daily doses of 0.5 and 1 mg/24h were not statistically significantly superior compared to placebo. The most common side effects were application site reactions, nausea and headache.
Up to 10% of the population experiences symptoms of “Restless Legs Syndrome”, which is characterized by an unpleasant restless urge and a tingling in the legs. These symptoms often manifest themselves in peaceful phases like periods of rest and inactivity, particularly in the evenings and at night, thus preventing recuperative sleep. RLS is a chronic, slowly progressive disease which occurs about as frequently as migraines or diabetes. It is presumed to be caused by a metabolic disorder of the nervous system.
SCHWARZ PHARMA (headquartered in Monheim, Germany) is a stock listed company with approximately 4,400 employees worldwide. The company develops novel medicines in the therapeutic areas of the central nervous system. Furthermore it markets innovative drugs focused to treat cardiovascular and gastro-intestinal diseases. In 2005 the SCHWARZ PHARMA group achieved global sales of nearly € 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.
Contact: Antje Witte, Tel: +49 2173 48 1866; Bettina Ellinghorst, Tel.: +49-2173 48 2329
This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation affecting SCHWARZ PHARMA AG, exchange rate fluctuations and hiring and retention of its employees.
Posted: January 2007