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UCB announced today that the company will submit a variation to the EMEA (European Medicines Evaluation Agency) to implement a full cold-chain storage and distribution system for Neupro (rotigotine transdermal patch) in Europe.
In agreement with the EMEA, over the next few months, UCB will be replacing current Neupro supply with product that has been refrigerated from manufacture.
Based on data generated to date, refrigerated storage of Neupro patches substantially reduces the development of crystals, which can result from the current manufacturing process. Crystallisation in the patch can lead to a change in visual appearance and can theoretically reduce its clinical efficacy, but it is of no clinical relevance in most instances.
To date, UCB has not seen a change in the pattern of clinically relevant adverse events, including lack of efficacy, which could be attributed to crystal formation.
All Neupro supply should be stored in a refrigerator. There is no need for patients to transport Neupro patches in special containers and they must not be stored in a freezer compartment.
In agreement with the EMEA, and in order to prioritise supply for existing patients, new patients will not be initiated on Neupro. The company is committed to working with the EMEA so that, as soon as possible, Neupro can be available again to all patients across Europe, including new patients with Parkinson’s Disease and Restless Legs Syndrome (RLS).
“I want to emphasise that the issue is not one of product contamination or toxicity,” said Iris Loew-Friedrich MD PhD, Chief Medical Officer, UCB. “Patients should use the patches they have and keep their supply in the refrigerator. Even if they notice crystals on their patch, it is important that patients do not stop taking their existing medication without speaking to their doctor.
“Over the next few months we will be systematically supplying Neupro that has been refrigerated from manufacture to pharmacies.”