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® 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®.
"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 affect patients
during the day as well as at 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. It can help patients manage the unpredictable nature of these
chronic conditions," said William Ondo, M.D., Professor, Department of
Neurology, University of Texas Health Science Center at Houston.
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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