ATLANTA, Oct. 8 /PRNewswire/ -- UCB, Inc. presented data from two
clinical trials that showed Neupro(R) (Rotigotine Transdermal System), a
once-daily non-ergolinic dopamine agonist patch, is effective in
controlling early morning motor impairment, provides improvement in sleep
quality, and is generally well-tolerated for long-term use in patients with
Parkinson's disease. Studies examining patients who have either early or
advanced-stage Parkinson's disease were also presented.
"Neupro offers continuous delivery of a dopamine agonist for 24 hours,
leading to stable plasma levels," said Rajesh Pahwa, M.D., Professor of
Neurology and Director of the Parkinson Disease and Movement Disorder
Center at the University of Kansas Medical Center. "These data showed that
Neupro has a positive effect on patients' early morning symptoms, improves
quality of sleep, and is generally well-tolerated for long-term use in
patients with Parkinson's disease." Dr. Pahwa is an investigator for the
long-term, open- label study.
An open-label, single-arm, exploratory 18-week study investigated the
efficacy of Neupro(R) on early morning motor impairment and sleep
disorders. Fifty-four patients with mostly advanced-stage Parkinson's
disease and unsatisfactory control of these symptoms received Neupro(R) in
doses from 4 to 16 mg/24 hours during a 4-week maintenance period. Motor
improvement upon waking and changes in sleep disturbances were assessed.
Forty-nine percent of patients treated per protocol with Neupro(R)
showed considerable improvement in early morning motor function sufficient
to meet response criteria (greater than or equal to 30% improvement of
UPDRS III score). Nocturnal akinesia -- inability to move at night -- was
reduced by 56%, and improvement was also noted in nocturnal dystonia --
painful muscle contraction -- and cramps. Neupro(R) improved sleep quality,
reduced excessive daytime sleepiness, decreased night-time urinary symptoms
(nocturias), and appeared generally well-tolerated. The most frequently
reported adverse events in patients treated with Neupro(R) were application
site reactions (20%), nausea (19%), and somnolence (11%).
Additionally, new, interim safety data from a four-year, open-label
extension of a separate pivotal Phase III, double-blind clinical trial were
presented. These data, in 216 patients with early-stage Parkinson's
disease, showed Neupro(R) was generally well-tolerated at 33 months of
treatment. Patients were tapered to their Neupro(R) starting dose and
re-titrated over a 3-week period. Neupro(R) doses were limited to less than
or equal to 6 mg/24 hours the first year, after which doses less than or
equal to 16 mg/24 hours were allowed.
The majority of participants (73%) remained in the study at 33 months,
with few discontinuations related to adverse events (13%) and a low
incidence of dyskinesia (6.5%). The most frequently reported adverse events
among patients treated with Neupro(R) in this trial were somnolence (41%),
application site reactions (23%), most of which were rated as mild (95%),
nausea (18%) and dizziness (20%).
"We are pleased to present important data which help demonstrate the
benefits of Neupro in patients with early and advanced-stage Parkinson's
disease," said Iris Loew-Friedrich, MD, PhD, Global Head of Development,
UCB. "We look forward to continuing the Neupro clinical development program
and are working to make this unique therapy available for U.S. patients
with advanced stages of the disease."
Neupro(R), with the active ingredient rotigotine, is a non-ergolinic
dopamine receptor-agonist formulated as a transdermal delivery system, a
patch, designed for once-a-day application. Neupro(R) is designed to mimic
the action of dopamine, a naturally-produced neurotransmitter crucial for
proper motor functioning. The system is applied to the skin once a day and
provides rotigotine continuously to the body for 24 hours. Patients
receiving Neupro(R) initiate treatment with a 2 mg/24 hours patch and
titrate in 2 mg/24 hours increments each week until the optimal effect is
observed, up to a maximum dose of 6 mg/24 hours. The administration of
Neupro(R) offers simple, once-daily dosing, and it is easy to use.
Neupro(R) is approved in the United States for the treatment of the
signs and symptoms of early-stage idiopathic Parkinson's disease, and in
Europe for the treatment of patients with early Parkinson's disease and in
combination with levodopa for advanced Parkinson's disease.
About Parkinson's Disease
Parkinson's disease is a progressive disorder of the central nervous
system. The patients -- roughly four million worldwide, including
approximately one million people in the United States -- suffer primarily
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 are drugs that attempt to compensate for this
lack of dopamine.
Important Safety Information
Neupro(R) is indicated for the treatment of the signs and symptoms of
early-stage idiopathic Parkinson's disease. Some patients treated with
Neupro(R) reported falling asleep while engaged in activities of daily
living, including operation of motor vehicles, which sometimes resulted in
accidents. Some patients perceived no warning signs, such as excessive
drowsiness. Hallucinations were reported in 2.0% of patients treated with
Neupro(R) compared to 0.7% of patients on placebo. Neupro(R) should be used
with caution in patients, especially those at risk for cardiovascular
disease, because of the potential for symptomatic hypotension, syncope,
elevated heart rate, elevated blood pressure, fluid retention, and/or
weight gain. All Parkinson's disease patients are at a higher risk for
melanoma and should be monitored regularly. The most commonly reported side
effects in clinical trials were nausea, application site reactions,
somnolence, dizziness, headache, vomiting, and insomnia. Some subjects who
received Neupro(R) experienced a decline in blood hemoglobin levels (about
2% relative to subjects who received placebo). It is not known whether this
change is readily reversible with discontinuation of Neupro(R). For full
prescribing information, please visit www.neupro.com.
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialisation of innovative pharmaceutical and biotechnology products
in the fields of central nervous system disorders, allergy/respiratory
diseases, immune and inflammatory disorders and oncology -- UCB focuses on
securing a leading position in severe disease categories. Employing more
than 10,000 people in over 40 countries, UCB achieved revenue of 3.5
billion euro in 2006 on a pro forma basis. UCB is listed on the Euronext
Brussels Exchange and owns approximately 88% of the shares of SCHWARZ
PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a member of UCB Group.
SOURCE UCB, Inc.