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The U.S. Food and Drug Administration
(FDA) today announced the approval of Neupro (rotigotine transdermal
system), a skin patch designed to treat symptoms of early
Parkinson's disease.
Rotigotine is a drug not previously approved in the United
States. Neupro is the first transdermal patch approved for the
treatment of symptoms of Parkinson's disease.
Parkinson's disease, which belongs to a group of conditions
called motor system disorders, results from the loss of
dopamine-producing brain cells. Rotigotine, a member of the dopamine
agonist class of drugs, is delivered continuously through the skin (transdermal)
using a silicone-based patch that is replaced every 24 hours. A
dopamine agonist works by activating dopamine receptors in the body,
mimicking the effect of the neurotransmitter dopamine.
The effectiveness of Neupro was demonstrated in one fixed-dose
response study and two flexible-dose studies. The parallel group
studies were randomized, double-blinded, and placebo-controlled, and
involved 1,154 patients with early Parkinson's disease who were not
taking other Parkinson's medications.
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The most common side effects for Neupro included skin reactions
at the patch site, dizziness, nausea, vomiting, drowsiness and
insomnia, most of which are typical of this class of drugs. Other
potential safety concerns include sudden onset of sleep while
engaged in routine activities such as driving or operating machinery
(sleep attacks), hallucinations, and decreased blood pressure on
standing up (postural hypotension).
Neupro Patch is manufactured by Schwarz Bioscience of Research
Triangle Park, N.C.
According to the Parkinson's Action Network, more than 1 million
Americans live with Parkinson's disease and 60,000 new cases are
diagnosed each year. The four primary symptoms of Parkinson's are
trembling in hands, arms, legs, jaw, and face (tremor); stiffness of
the limbs and trunk (rigidity); slowness of movement (bradykinesia,);
and impaired balance and coordination (postural instability). As
these symptoms become more pronounced, patients may have difficulty
walking, talking, or completing other simple tasks.
For more information:
National Institute of Neurological Disorders and Stroke
[Text copied
from U.S. Food and Drug Administration
news release]
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