The US Food and Drug Administration (FDA) has provided a complete response letter toUCB recommending reformulation of Neupro (Rotigotine Transdermal System) before making it available in the U.S. market for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS). US FDA's response is to an NDA Supplement that UCB submitted in June 2009, with a proposal for new refrigerated storage conditions to alleviate crystallization on the patches.
"US FDA agrees that the proposed new refrigeration conditions significantly inhibit the degree of crystallization on the patches, but has recommended that the definitive resolution of the crystallization is to reformulate the drug product," said professor Dr Iris Loew-Friedrich, executive vice president and chief medical officer of UCB. "This US FDA decision does not impact product supply and availability in Europe and the rest of the world. It does not change previous assessments made by the European and other international authorities regarding the cold chain storage process."
More than 50 000 patients are being treated by Neupro in Europe. In the US, a Patient Access Program is ongoing and UCB will continue this programme.
"We have already been working on a room-temperature stable, improved formulation of Neupro and have made significant progress in this area," the chief medical officer of UCB added. "Neupro has made a meaningful difference for many people with Parkinson's disease and Restless Legs Syndrome. We are committed to obtaining US FDA approval so that people in the US who live with these diseases can benefit from Neupro."
Neupro (rotigotine) is approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occurs.