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Neupro® Receives Approvable Letter from FDA for Early Parkinson's Disease in USA |
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02 Mar 2006 |
After Neupro® was approved in Europe recently, SCHWARZ PHARMA is now confident being able to launch the drug in the USA.After Neupro® was approved in Europe recently, SCHWARZ PHARMA is now confident being able to launch the drug in the USA.
MONHEIM, Germany | Mar 01, 2006 | SCHWARZ PHARMA announced today that it has received an action letter from the US Food and Drug Administration (FDA). The FDA states that Neupro® (rotigotine transdermal system) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease is approvable.
"This is a big positive step forward for the product. We anticipate responding to the action letter within six months ", comments Iris Loew-Friedrich, MD, PhD, Member of the Executive Board SCHWARZ PHARMA AG. "The FDA requires additional analyses and summaries from the existing database."
Mid of February 2006, the European Commission adopted the European Medicines Agency’s (EMEA) positive opinion granting marketing authorization for Neupro® for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy. SCHWARZ PHARMA will launch Neupro® in the first European markets within the next few weeks.
Neupro®, with the active ingredient rotigotine, is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once a day application and provides rotigotine continuously to the body for 24 hours. Multinational clinical studies in patients with early stage Parkinson's disease were completed at the end of 2003. In 15 clinical trials, more than 1,500 patients with Parkinson’s disease have been treated with rotigotine transdermal patch. Rotigotine exhibits a D3/D2/D1 receptor profile, rapid metabolism and low potential of pharmacokinetic drug-drug interactions. The patch administration of rotigotine offers the convenience of once daily-dosing as well as a simple titration scheme.
Results of a rotigotine phase III study conducted in Europe show that rotigotine transdermal patch is also effective in treating patients with advanced Parkinson’s disease. This outcome confirms favorable results from a phase III study completed in the USA at the end of 2004. SCHWARZ PHARMA plans to submit marketing applications in the US and Europe at the end of 2006.
SCHWARZ PHARMA is also developing a rotigotine patch for treating Restless Legs Syndrome. The double-blind and placebo-controlled phase III trial program started in May 2005; first results are expected in the first quarter of 2007.
Parkinson’s disease is a disorder of the central nervous system. The patients - roughly four million worldwide - 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.
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SCHWARZ PHARMA AG (headquartered in Monheim, Germany) develops and markets innovative drugs for unmet medical needs with focus on neurology, urology and cardiovascular 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, USA and Asia. Shares of SCHWARZ PHARMA AG are traded on the Frankfurt and Duesseldorf stock exchanges.
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.
source: SCHWARZ PHARMA AG |
