US FDA Approves SCHWARZ PHARMA's Neupro (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease in USA
SCHWARZ PHARMA announced on May 9th that the U.S. Food and Drug Administration (FDA) has approved Neupro(R) (Rotigotine Transdermal System) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease.
"This is an important step forward for the patients suffering from Parkinson's disease. Following approval and launch within Europe, Neupro will now be available for patients in the USA," comments Iris Loew-Friedrich, MD, PhD, CSO SCHWARZ PHARMA AG. "We intend to submit a supplemental New Drug Application for the treatment of advanced Parkinson's
disease to the FDA by the end of 2007."
Neupro, with once daily dosing, is the first non-ergolinic dopamine agonist transdermal system capable of delivering medication over a 24-hour period. The once-daily transdermal patch Neupro will be available in the U.S. in three strengths (2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours).
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. Rotigotine is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. The system is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Multinational clinical studies in patients with 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 system. The clinical trials have shown efficacy and safety in early Parkinson's disease. Rotigotine exhibits a low potential of pharmacokinetic drug-drug interactions. The administration of rotigotine transdermal system offers the convenience of once daily dosing and easy usage.
Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinson's disease in combination with levodopa. Since March 2006, the drug has been available on the European market and has been launched by SCHWARZ PHARMA in 14 countries within Europe, e.g. Germany, the UK, Austria, Denmark, Ireland, Norway,
Switzerland, Sweden, Greece, Spain, Finland and Poland.
Parkinson's disease is a progressive disorder of the central nervous system. The patients - roughly four million worldwide, including approximately one million people in the U.S. - suffer primarily 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 are drugs that attempt to compensate for this lack of dopamine. -Shwarz Pharma
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