UCB advises US-physicians to down-titrate patients on Neupro(R) in view of out-of-stock situation in the US

MARKETWIRE

Mar 20, 2008 BRUSSELS, BELGIUM MARKET WIRE
http://www.genengnews.com/news/bnite...?name=32425368

UCB initiates recall of Neupro(R) batches, which will lead to an out-of-stock situation in the United States in late April.

Patients in the US are advised to contact their healthcare provider. Neupro(R) supply is sufficient in other regions.

Brussels, Belgium - March 20, 2008 at 7:00 am CET - UCB announced today that the company will be recalling Neupro(R) (rotigotine transdermal system) in the United States and certain batches in Europe. The recall decision resulted from ongoing monitoring of marketed product, which revealed a deviation from the approved product specification. As a result, there will be an out-of-stock situation with Neupro(R) in the United States in late April 2008. In the European Union and most other regions Neupro(R) supply is sufficient.

"We have informed the FDA and agreed to actions to inform healthcare providers and patients," said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, UCB. "We advise patients in the US to contact their healthcare provider to begin the down-titration of Neupro(R) as per the guidelines in the label. It is strongly advised that patients do not discontinue therapy abruptly. I also want to emphasize that the issue is not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches."

Down-titration (reduction of the dose) should be gradual and performed under medical supervision. Rapid reduction of therapy for Parkinson's disease has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.