Schwarz Pharma announces that the European Commission has given marketing authorization for Neupro (rotigotine transdermal patch), for the treatment of all stages of Parkinson's disease.
Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on-off" fluctuations), a company press release stated.
"Transdermal administration of a dopamine agonist offers a promising option for patients suffering from Parkinson'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."
Neupro is available in the European market since March 2006 for the treatment of early stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa). The drug has already been launched by Schwarz Pharma in Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece and Spain.
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. It, therefore, covers symptoms not only during the day, but also at night. 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.
Schwarz Pharma is a pharmacutical 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.