UCB has received complete response letter from FDA recommending reformulation of Neupro (Rotigotine Transdermal System) before making it available in the US market for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS).
UCB said that FDA’s response is to an NDA Supplement, which was submitted by the company in June 2009, with a proposal for new refrigerated storage conditions to alleviate crystallization on the patches.
According to the company, 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. Neupro is also approved for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults.
Iris Loew-Friedrich, executive vice president and chief medical officer of UCB, said: “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.
“This 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.
“We have already been working on a room-temperature stable, improved formulation of Neupro and have made significant progress in this area. Neupro has made a meaningful difference for many people with Parkinson’s disease and Restless Legs Syndrome. We are committed to obtaining FDA approval so that people in the US who live with these diseases can benefit from Neupro.”