In conjunction with the U.S. launch, the companies are also kicking off PDAware, a public education campaign which aims to raise the profile of Parkinson's disease. The campaign will highlight the experiences and personal achievements of Parkinson's patients in order to increase understanding of the disease and highlight the latest treatment options, including Neupro®.
"Disabling Parkinson's symptoms can be well controlled with available medications, but may return as the effects of Parkinson's disease medications wear off," said C. Warren Olanow, M.D., Professor and Chair of Neurology, and Professor of Neuroscience at the Mount Sinai School of Medicine in New York City. "Neupro® is the first transdermal or patch formulation available for the treatment of Parkinsonâs disease. It provides continuous drug delivery for 24 hours, throughout the day and night. As a new treatment option for early-stage Parkinson's patients, the Neupro® patch helps control symptoms with once-daily dosing."
The U.S. Food and Drug Administration (FDA) approved Neupro® on May 9, 2007 based on results from 15 multinational clinical trials, which involved more than 1,500 patients with Parkinsonâs disease. The clinical trials demonstrated that Neupro® was efficacious and generally well-tolerated for early-stage Parkinson's disease, with a low potential for drug-drug interactions. Neupro® is currently available in the United States in three strengths: 2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours.
"The FDA's approval of Neupro® as a therapy for many Parkinson's disease patients is a momentous achievement for our company," said Rich Denness, Chief Executive Officer of SCHWARZ PHARMA Inc., USA. "We are proud to offer an effective treatment that controls the symptoms of early-stage Parkinson's disease by providing stable, continuous delivery of medication over a 24-hour period. We are excited to continue working with physicians and their patients who have Parkinson's disease, and we remain committed to educating the Parkinson's community about this new therapy."
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. Neupro® 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. Patients receiving Neupro® initiate treatment with a 2 mg/24 hours patch and titrate in 2 mg/24 hours increments each week until the optimal effect is observed. The administration of rotigotine transdermal system offers simple, once-daily dosing, and it is easy to use.
Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinsonâs disease in combination with levodopa. Since March 2006, the drug has been available on the European market and has been launched by SCHWARZ PHARMA AG in 14 countries within Europe, including Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece, Spain, Finland, Poland, Slovakia and the Czech Republic.