FDA News

FDA Approves SCHWARZ PHARMA's Neupro® (Rotigotine Transdermal System) For Treatment Of Early-stage Parkinson's DIsease

(May 10, 2007)-- SCHWARZ PHARMA announced today that the U.S. Food and Drug Administration (FDA) has approved Neupro (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.

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