Neupro(R) (Rotigotine Transdermal System) Effective in Controlling Early Morning Motor Impairment and Generally Well-Tolerated for Long-Term Use in Patients with Parkinson's Disease

- Data Presented at the 132nd Annual Meeting of the American Neurological

Association in Washington, D.C. -

Oct 08, 2007, 01:00 ET from UCB, Inc.

    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."
     About Neupro(R)
     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
     About UCB
     UCB, Brussels, Belgium ( 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.