On January 16, the European Commission (EC) approved an expanded indication for rotigotine transdermal patch (Neupro, made by Schwarz Pharma AG), allowing its use in combination with levodopa through the course of Parkinson's disease (PD) to the late stages when the therapeutic efficacy of levodopa may fluctuate.
Rotigotine is a nonergoline dopamine receptor agonist formulated as a patch for 24-hour transdermal delivery, which is intended to provide symptomatic relief throughout the day and night.
According to a company news release, multinational clinical studies of patients (N > 2000) in early and advanced stages of PD have demonstrated the drug's efficacy and safety as well as a potential long-term benefit. Rotigotine exhibits a promising receptor profile, rapid metabolism, and low potential of pharmacokinetic drug-drug interactions.
The rotigotine patch was previously approved by the EC as monotherapy for the treatment of early-stage idiopathic PD. According to a company news release, it has been launched in Germany, the United Kingdom, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece, and Spain. Rotigotine has not been approved by the US Food and Drug Administration.
Source: http://www.neupro.virtuale.org
