Friday, April 06, 2012
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Belgian drug maker, 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). Neupro® was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD.
"Neupro® represents an innovation in the treatment of Parkinson's disease and restless legs syndrome," The continuous drug delivery patch was first approved by the FDA in 2007 to treat early-stage Parkinson's."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. It can help patients manage the unpredictable nature of these chronic conditions.
About UCB:
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011.
Clinical data:
The effectiveness of Neupro® in the treatment of the signs and symptoms of idiopathic PD was established in five parallel group, randomized, double-blind placebo-controlled trials conducted in the U.S. and abroad. Depending on trial design, patients underwent a weekly titration of Neupro® in 2 mg/24 hours increments to either the randomized dose or optimal dose.
Mechanism of action:
The dopamine agonist skin patch is believed to work by stimulating dopamine receptors within the caudate-putamen, the portion of the brain that regulates movement, the company said.
About Neupro® in the U.S:
Neupro® (Rotigotine Transdermal System) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS).
About Neupro® in the European Union:
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 occur (end of dose or on-off fluctuations). Neupro® is also approved in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.
Side effects:
In clinical testing, observed side effects of Neupro included nausea, vomiting, skin site reactions, dizziness, insomnia and headache.
Neupro contains sodium metabisulfite, which could cause deadly allergic-like reactions in certain susceptible people. Also, the drug should not be used by pregnant women, UCB warned.
Warning: Should not be used in Pregnant woman.
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