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Schwarz Pharma' Neupro to get approval for treatment of Parkinson's disease

Monday, November 20, 2006 09:00 IST
Germany
http://www.pharmabiz.com/article/det...rticleid=36152

Schwarz Pharma has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the extension of the marketing authorization for Neupro (rotigotine transdermal patch), for the treatment of patients with advanced stage Parkinson's disease as combination therapy.

Upon receipt of approval, Schwarz Pharma will be able to market Neupro for patients with advanced Parkinson's disease throughout all 25 European Union countries. Neupro is already approved and on the market in Europe for the treatment of patients with early stage Parkinson's disease as monotherapy.

"Transdermal administration of a dopamine agonist offers a promising option for patients suffering from Parkinsons's disease," says Iris Loew-Friedrich, MD, PhD, CSO Schwarz Pharma AG. "Rotigotine, a new chemical entity, is combined with an innovative formulation technology, the first Parkinson's patch, to offer patients good symptom control over twenty-four hours. In the clinical trials we have observed a noticeable increase in 'on' time without troublesome dyskinesia - an important parameter for patients."

Neupro, with the active ingredient rotigotine, is a non-ergoline dopamine receptor-agonist formulated as a transdermal delivery system, a patch. The patch is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours.

Multinational clinical studies with patients in early and advanced stages of Parkinson's disease have shown efficacy and safety in Parkinson's disease patients and a potential for long term benefit. In more than 20 clinical trials, more than 2,000 patients with early or advanced Parkinson's disease have been treated with rotigotine transdermal patch. Rotigotine exhibits a promising receptor profile, rapid metabolism and low potential of pharmacokinetic drug-drug interactions. The patch administration of rotigotine offers the convenience of once daily-dosing and easy usage.

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.