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. Neupro is the first once daily patch designed to treat these symptoms.
The once-daily Neupro patch will be available in the U.S. in three strengths (2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours).
Parkinson’s disease is a degenerative disorder of the central nervous system that impairs a person’s motor skills and speech. People with Parkinson’s disease often experience muscle rigidity, tremors, a slowing of physical movement and, in extreme cases, a loss of physical movement (akinesia). Parkinson’s disease is both chronic and progressive.
Neupro’s active ingredient is rotigotine, a dopamine receptor-agonist, and is formulated as a patch (or “transdermal delivery system”), 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 the rotigotine patch, which has been shown both safe and effective in early Parkinson’s disease.
Rotigotine exhibits a low potential of pharmacokinetic drug-drug interactions.
“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 ,” noted Iris Loew-Friedrich, MD, PhD, Chief Science Officer of Scharz 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.”
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 .
People with Parkinson’s disease — 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.