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Rotigotine (available in Europe as a transdermal patch under the brand name Neupro) has been shown to be effective in two randomized Phase III trials (Schwarz Pharma communication January 2007) which served as a basis for submission to EMEA in this indication (company communication December 2007). On 25 April 2008, UCB-Schwarz Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) had recommended approval of rotigotine in the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults. Neupro is nevertheless not approved yet (as of October 2008) by EMEA for RLS because UCB-Schwarz Pharma has had stability issues with the transdermal patch, and has announced that they would file a manufacturing variation with EMEA to solve these problems. In the meantime, no new patients can be initiated on Neupro, and those already treated (for Parkinson's disease) must store the patches in the refrigerator (company communication June 2008).

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