SAN DIEGO, April 6 /PRNewswire/ -- SCHWARZ PHARMA today presented results at the 58th Annual Meeting of American Academy of Neurology (AAN) from an open-label extension of a Phase III trial of rotigotine transdermal patch, a non-ergolinic dopamine agonist, currently under investigation in the U.S. for Parkinson’s disease. As reported earlier the multi-center, double-blind, placebo-controlled trial preceding the open-label long-term extension demonstrated that Parkinson’s disease patients treated with rotigotine showed statistically significant improvement in the Unified Parkinson Disease Rating Scale (UPDRS). In this interim analysis of the open-label extension, rotigotine was shown to be well tolerated and to improve the symptoms of early-stage Parkinson’s disease.
“These latest open-label data demonstrate rotigotine transdermal patch administered once-daily reduced the frequency and severity of early Parkinson’s disease symptoms and was well tolerated,” said Ray L. Watts, MD, Chair, Department of Neurology, University of Alabama at Birmingham.
Long-Term Safety and Efficacy in Early-Stage Parkinson’s Disease
As part of an ongoing, open-label extension to a previous study, patients with early-stage Parkinson’s disease who had completed six months of double-blind treatment were eligible for inclusion. Of the 216 patients comprising the safety population at the initiation of the open-label phase, 208 patients also had efficacy data. Before entering a maintenance phase, patients were titrated over a three-week period using rotigotine ranging from 2 mg/24 h (10 cm(2)) to 6 mg/24 h (30 cm(2)). Dose escalations up to a total of 16 mg/24 h (80 cm(2)) were permitted after one year of open-label treatment.
Efficacy was measured using UPDRS Parts II and III, which assess a patient’s ability to perform everyday activities and evaluate motor systems of Parkinson’s disease. The UPDRS scores were compared with the scores collected in the double-blind trial at baseline. The results revealed that early initiation of rotigotine may indicate a long-term advantage. Early in the open-label extension, a similar percentage of patients from the original treatment groups achieved a 20 percent or greater reduction in their UPDRS scores (Parts II and III). Additionally, 31 percent of patients who remained on rotigotine from the start of double-blind treatment maintained improvement on UPDRS for at least 85 weeks versus 20 percent of patients originally randomized to placebo. Overall, patients experienced better long-term outcomes when treated with rotigotine compared to placebo. The most common side effects were somnolence, application site reactions (ASRs), nausea and dizziness.
Original Early-Stage Parkinson’s Disease Trial
In the original, double-blind, placebo-controlled study, 273 patients with early-stage Parkinson’s disease were assigned to receive either rotigotine (n=177) or placebo (n=96) for six months. For the rotigotine treatment, patients were started on a 2 mg/24 h (10 cm(2)) patch, increasing the dose by 2 mg/24 h (10 cm(2)) each week over three weeks to a maximum dose of 6 mg/24 h (30 cm(2)). The researchers measured changes in scores on parts II and III of the UPDRS.
During the study, patients in the rotigotine group showed an average improvement of 3.8 points in their UPDRS scores from baseline compared to the placebo group, whose scores worsened by an average of 1.5 points from baseline. The most common side-effects were ASRs, nausea, somnolence and dizziness.
About Rotigotine Transdermal Patch
Rotigotine is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once-a-day application. Rotigotine is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning.
SCHWARZ PHARMA filed a New Drug Application (NDA) for rotigotine with the U.S. Food and Drug Administration (FDA) in January 2005 and with the European Agency for the Evaluation of Medicinal Products (EMEA) in September 2004 for the treatment of early-stage Parkinson’s disease. SCHWARZ PHARMA received an approvable letter from the FDA on February 28, 2006. Rotigotine was approved by the EMEA on February 20, 2006.
About Parkinson’s Disease
Parkinson’s disease is a progressive disorder of the central nervous system. The patients -- roughly four million worldwide, including approximately 1.5 million people in the U.S. -- suffer from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists attempt to compensate for this lack of dopamine.
SCHWARZ PHARMA, Inc. is the US Marketing and Sales organization within the SCHWARZ PHARMA group. SCHWARZ PHARMA AG (headquartered in Monheim, Germany) develops and markets innovative drugs for unmet medical needs with a focus on neurology, urology, cardiovascular and gastrointestinal diseases. The company is investing in development projects targeting diseases such as Parkinson’s disease, restless legs syndrome, epilepsy, neuropathic pain and overactive bladder syndrome. The company has a strong international presence with subsidiaries in Europe, the United States and Asia. Shares of SCHWARZ PHARMA AG are traded on the Frankfurt and Duesseldorf stock exchanges.
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Corporate Communications: 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.
Contact: Bettina Ellinghorst +49 2173 48 2329 bettina.ellinghorst@schwarzpharma.com
SCHWARZ PHARMA
CONTACT: Bettina Ellinghorst of SCHWARZ PHARMA, +49 2173 48 2329,bettina.ellinghorst@schwarzpharma.com
Web site: http://www.schwarzpharma.com/
