Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending marketing authorisation for Schwarz Pharma's Neupro (rotigotine transdermal patch), for the treatment of Parkinson's disease as monotherapy. Upon receipt of approval, Schwarz Pharma will be able to market Neupro throughout all 25 European Union countries.
"This positive opinion is a milestone for our company. We are delivering on our strategy to develop and market innovative drugs in the areas of neurology and urology," said Patrick Schwarz-Schütte, CEO Schwarz Pharma AG.
"We are now getting ready for the market introduction of Neupro within Europe in the first half of 2006. Transdermal administration of a dopamine agonist offers a promising option for patients suffering from early Parkinsons's disease," said Iris Loew-Friedrich, chief scientific officer 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," added Loew-Friedrich.
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, informs a company release.
Multinational clinical studies with patients in early stages of 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. The clinical trials have shown efficacy and safety in early Parkinson's disease patients and a potential for long term benefit. 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 AG 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.