Navigation Links
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. -

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 <6 mg/24 hours the first year, after which doses <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.

Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
2. NuPathe Reports Positive Phase One Results for NP101 Transdermal Therapy for Acute Migraine
3. Daytrana (methylphenidate transdermal system) Provides Significant Effectiveness in ADHD Symptom Relief in Both Boys and Girls
4. 12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA (methylphenidate transdermal system)
5. Phosphagenics to Commence Phase 1b Transdermal Insulin Clinical Trial in Second Quarter
6. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
7. Eurands Zentase Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show
8. Cimzia Effective in Reducing Signs and Symptoms of Rheumatoid Arthritis
9. Gabapentin Shown Effective for Fibromyalgia Pain
10. ApoCells Cancer Predictive Index Helps Oncologists Select the Most Effective Targeted Drug Therapy
11. Roxro Pharma’s Novel Intranasal Pain Reliever Effective, Well Tolerated in Phase 3 Study
Post Your Comments:
(Date:11/24/2015)... , Nov. 24, 2015  Array BioPharma Inc. ... Chief Executive Officer, Ron Squarer , will ... in New York.  The public is welcome to ... the Array BioPharma website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  ... December 2, 2015Time:1:30 p.m. Eastern Time Webcast: ...
(Date:11/24/2015)... and VANCOUVER, Nov. 24, 2015 /PRNewswire/ - ESSA ... EPIX ) announced today that the first patient ... of EPI-506 as a treatment for metastatic castration-resistant prostate ... and Canada.  --> the ... In the Phase 1/2 clinical trial, ESSA intends ...
(Date:11/24/2015)... COMMACK, New York , 24. November ... Hersteller des Avery Breathing Pacemaker Systems, ist ... Ph.D., als Clinical Consultant bekannt geben zu ... -->   --> ... Stockholm (Schweden). Von 1984-1986 ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... 24, 2015 , ... With Thanksgiving right around the corner, holiday travel season ... protect your family and vehicle. , According to the National Highway Traffic Safety Administration, ... is sharing the following safety tips from the NHTSA: , ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... it has been designated an Aetna Institute of Quality® Bariatric Surgery Facility for ... the quality and cost of health care services available to its members to ...
(Date:11/24/2015)... M.D. (PRWEB) , ... November 24, 2015 , ... ... new award for its exceptional customer service: the TrustDale certification. The award recognizes ... The Baltimore stone honing , tile and grout, and hard surface restoration ...
(Date:11/24/2015)... ... , ... Autism Speaks, the world’s leading autism science and advocacy organization, will ... generosity of people around the world. On December 1, supporters can make an online ... share the personal stories behind those gifts. , Just as Black Friday and ...
(Date:11/24/2015)... ... ... All her life, Don Peck’s mother wondered if she was a descendant of Samuel Fuller, ... After a 25-year search for information, Don and his aunt discovered that she was not, ... Turns out, it was Don’s father who was descended from not one, but four passengers ...
Breaking Medicine News(10 mins):