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- In Europe, SCHWARZ PHARMA's Parkinson's patch has been also
approved for the treatment of the signs and symptoms of advanced-
stage Parkinson's disease in combination with levodopa.
SCHWARZ PHARMA announces that the European Commission has given
marketing authorization for Neupro® (rotigotine transdermal patch),
for the treatment of all stages of Parkinson's disease. Neupro® is
indicated 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).
"Transdermal administration of a dopamine agonist offers a promising
option for patients suffering from Parkinson's disease," says Iris
Loew-Friedrich, MD, PhD, CSO SCHWARZ PHARMA AG. "Rotigotine, a new
chemical entity, is combined with an innovative formulation
technology, the first Parkinson's patch, to offer patients good
symptom control over twenty-four hours."
Neupro® is available in the European market since March 2006 for the
treatment of early stage idiopathic Parkinson's disease as
monotherapy (i.e. without levodopa). The drug has already been
launched by SCHWARZ PHARMA in Germany, the UK, Austria, Denmark,
Ireland, Norway, Switzerland, Sweden, Greece and Spain.
Neupro®, with the active ingredient rotigotine, is a non-ergoline
dopamine receptor-agonist formulated as a transdermal delivery
system, a patch. The patch is applied to the skin once a day and
provides rotigotine continuously to the body for 24 hours. It,
therefore, covers symptoms not only during the day, but also at
night. Multinational clinical studies with patients in early and
advanced stages of Parkinson's disease have shown efficacy and
safety in Parkinson's disease patients and a potential for long term
benefit. In more than 20 clinical trials, more than 2,000 patients
with early or advanced Parkinson's disease have been treated with
rotigotine transdermal patch. Rotigotine exhibits a promising
receptor profile, rapid metabolism and low potential of
pharmacokinetic drug-drug interactions. The patch administration of
rotigotine offers the convenience of once daily-dosing and easy
usage.
Parkinson's disease is a disorder of the central nervous system. The
patients - roughly four million worldwide - suffer from a lack of
dopamine, a messenger substance in the central nervous system, which
is responsible for the coordination of movement. As a result of this
shortage, patients are no longer able to control their movements
reliably. Dopamine agonists attempt to compensate for this lack of
dopamine.
SCHWARZ PHARMA (headquartered in Monheim, Germany) is a
pharmacutical company with approximately 4,400 employees worldwide.
The company develops novel medicines in the therapeutic areas of the
central nervous system. Furthermore it markets innovative drugs
focused to treat cardiovascular and gastro-intestinal diseases. In
2005 the SCHWARZ PHARMA group achieved global sales of nearly € 1
billion. The company has a strong international presence with
subsidiaries in Europe, USA and Asia.
MONHEIM, Germany, 1/16/07(PharmaLive)
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