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SCHWARZ PHARMA Reports Positive Results for Rotigotine in Restless Legs Syndrome |
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10 Oct 2006 |
First phase III results with Rotigotine transdermal patch in patients suffering from Restless Legs Syndrome show clinically relevant and statistically significant reduction in symptoms. This trial has the potential to be considered as a pivotal trial. First results from a second phase III trial are due in Q1/2007.
MONHEIM, Germnay | Oct 09, 2006 | SCHWARZ PHARMA announced today that the multinational 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 highly statistically significant reduction of RLS symptoms versus placebo in both primary variables. Rotigotine was also well tolerated in this trial.
Iris Loew-Friedrich, MD, PhD, Member of the Executive Board SCHWARZ PHARMA AG said: “We are encouraged by the magnitude of the reduction of Restless Legs Syndrome symptoms and the good tolerability, which patients experienced during the trial. For all doses tested, a clinically relevant and statistically significant reduction of symptoms was reported. The improvement has been measured with the validated International Restless Legs Syndrome Study Group Rating Scale, IRLS."
In this trial, 458 patients with moderate to severe RLS were treated in a double-blind, placebo-controlled phase III study. All patients began the three-week titration period at a daily dose of 2.25mg rotigotine transdermal patch or placebo. During the six-month period of treatment, the patients received rotigotine transdermal patch (2.25, 4.5 or 6.75 mg/day) or placebo patch on a daily basis. Co-primary endpoints were absolute change from baseline in the IRLS and in the Clinical Global Impression (CGI) item 1 score (severity of illness) at the end of maintenance period.
Rotigotine treatment led to a clinically relevant and statistically significant reduction in the IRLS score and in the CGI item 1 score. The rotigotine transdermal patch achieved a statistically significant improvement compared to placebo. The most common side effects were application site reactions, nausea, headache and fatigue.
“Restless Legs Syndrome” is also known as Ekbom’s Syndrome. Up to 10% of the population experiences symptoms of this neurological disease 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
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SOURCE: SCHWARZ PHARMA |
