"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 United States," comments Iris Loew-Friedrich, M.D., Ph.D., 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. Multi-national 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 the Rotigotine transdermal system offers the convenience of once daily dosing and easy usage.
The 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 European countries.
Important Safety Information
My Parkinson's Info works to share all of the information, including the possible negative side of any treatments. Neupro was found to have a proven safety and tolerability profile. The most frequently reported adverse events in clinical trials were nausea, application site reactions, somnolence, dizziness, headache, vomiting, and insomnia. Other adverse effects with Neupro included peripheral edema, fluid retention, hallucinations, symptomatic orthostatic hypotension, weight gain, elevated heart rate, elevated blood pressure, and syncope. Neupro is contraindicated in patients who have demonstrated hypersensitivity to Rotigotine or to the components of the transdermal system. Neupro contains sodium metabisulfite which may cause allergic-type reactions including anaphylactic symptoms in people who may be sensitive to sulfites, including those with asthma.