SCHWARZ ANNOUNCES PUBLICATION OF DATA ON PARKINSON'S PATCH

Schwarz Pharma has announced the publication online of a Phase III clinical trial in the journal Neurology. The trial showed positive results of its once daily dopamine agonist, rotigotine, for the treatment of early stage Parkinson's disease. Rotigotine is a non-ergolinic dopamine receptor-agonist formulated as a transdermal patch.

The multicenter, randomized, double-blind study was designed to evaluate the safety and effectiveness of the once-daily dopamine agonist rotigotine, supplied via a once-daily transdermal patch that delivers the drug continuously, versus placebo in patients with early stage Parkinson's. The study found that rotigotine, when titrated to a dose of 6 mg in 24 hours, was effective for the treatment of early stage Parkinson's. In addition, rotigotine appeared to be well tolerated by patients.

The Phase III clinical trial evaluated 302 patients with early stage, idiopathic Parkinson's at 50 clinical study sites in the United States and Canada. A total of 277 patients were randomized to receive placebo or rotigotine. The rotigotine group started treatment with the 2-mg-per-24-hour patch and titrated weekly up to a maximum dose of 6 mg in 24 hours. The 27-week study period included a three-week titration phase, followed by a 24-week maintenance phase. There was also a four-week pretreatment phase and a four-week safety follow-up phase. The primary efficacy measure was the change from baseline in parts II and III of the Unified Parkinson Disease Rating Scale score, which assesses a patient's ability to perform everyday activities and also evaluates motor symptoms of Parkinson's.

Rotigotine is currently marketed in Europe as monotherapy for early stage Parkinson's and has received a favorable review for advanced stage Parkinson's.