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UCB’s Neupro cleared for advanced Parkinson’s and RLS in US

FDA approval adds to early stage Parkinson’s indication

UCB

The US Food and Drug Administration (FDA) has approved UCB's Neupro for use in the treatment of restless legs syndrome (RLS), as well as a further indication in Parkinson's disease.

The drug can now be marketed in the US for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's and as a treatment for moderate-to-severe primary RLS, a disorder where the patient has uncontrollable urges to move the limbs to stop painful sensations in the body.

Previously, Neupro (rotigotine transdermal system) had only been available as a treatment for early stage Parkinson's.

The expanded Parkinson's approval is based on several trials that demonstrated a significant improvement in a patient's symptoms compared to placebo following a period of 'off-time' when the effectiveness of medications wears off and Parkinson's symptoms return.

Clinical trials involving the drug in the treatment of RLS demonstrated significant improvements in sum scores on the International RLS Rating Scale (IRLS Scale) and the Clinical Global Impression - Improvement (CGI-I) assessment for patients taking Neupro compared to placebo.

"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,” said Dr William Ondo professor of the department of neurology at the University of Texas' Houston Medical School.

“Neupro provides a novel way of treating RLS and PD through continuous transdermal dopaminergic delivery. It can help patients manage the unpredictable nature of these chronic conditions."

This transdermal delivery system means the drug can be continuously delivered to patients.

It is designed to work by stimulating a person's dopamine receptors within the caudate-putamen, the region of the brain that regulates movement, although the precise method of action is unknown according to UCB.

In Europe, Neupro is approved for as a monotherapy for early-stage Parkinson's disease, or in combination with levodopa at any stage of the disease. It also available as a treatment for moderate to severe RLS.

4th April 2012

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