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Neupro FDA approvals extended


UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro® (rotigotine transdermal system) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson’s disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

Rotigotine is currently approved in Europe for use alone, or as an adjunct to co-beneldopa, for treatment of PD, and for treatment of moderate to severe RLS.

It was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD.

Neupro® is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. The FDA has also approved UCB’s new formulation of Neupro®.

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“Neupro® represents an innovation in the treatment of Parkinson’s disease and restless legs syndrome,” said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President of Global Projects and Development at UCB. “UCB is thrilled to make Neupro® available to patients living with these serious diseases.”

“RLS can be a serious condition with symptoms that can affect patients at any point in the day or night; and Parkinson’s disease symptoms can have a broad impact on patients. Neupro® provides a novel way of treating RLS and PD through continuous transdermal dopaminergic delivery,” said William Ondo, M.D., Professor, Department of Neurology, University of Texas at Houston Medical School, Adult and Pediatric Movement Disorders.

“It can help patients manage the unpredictable nature of these chronic conditions.”

As a PD treatment, the mechanism of action of Neupro® is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen, the region of the brain that regulates movement. Similarly, in RLS, the mechanism of action of Neupro® may be related to its ability to stimulate dopamine receptors. The precise mechanism of action of Neupro as a treatment for these diseases is unknown.


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