Navigation Links
Neupro(R) Filed with the FDA for the Treatment of Restless Legs Syndrome
Date:12/13/2007

The U.S. Food and Drug Administration (FDA) has accepted for filing the

Supplemental New Drug Application (sNDA) for the use of Neupro(R) (Rotigotine Transdermal System) as a treatment for moderate-to-severe

restless legs syndrome (RLS)

ATLANTA, Dec. 13 /PRNewswire/ -- UCB announced today that the supplemental New Drug Application (sNDA) for the use of Neupro(R) as a treatment for moderate-to-severe restless legs syndrome (RLS) has been accepted for filing by the U.S. Food and Drug Administration (FDA). Neupro(R) is a patch designed to provide continuous drug delivery. Restless legs syndrome is a chronic neurological disorder that affects between three and ten percent of the population.

"The acceptance of the sNDA underscores our ongoing commitment to provide innovative therapies for patients living with debilitating central nervous system disorders," said Troy Cox, President CNS Operations, UCB.

The submission is based on two fixed-dose, randomized, double-blind, placebo-controlled efficacy and safety studies that evaluated rotigotine for the treatment of moderate-to-severe idiopathic RLS in approximately 1,000 patients over six months. In these trials, rotigotine produced statistically significant reductions in RLS symptoms and was generally well-tolerated. The efficacy of rotigotine was evaluated by monitoring the International Restless Legs Severity Scale (IRLS), a clinician-administered tool considered to be the best scale for evaluating the severity and frequency of RLS symptoms and the degree to which they affect sleep and daily life. The most frequently reported adverse events associated with rotigotine in these studies were application site reactions, nausea, dizziness, somnolence and headache.

"This chronic condition can be serious and even debilitating with many patients requiring treatment that offers sustained symptom control," said rotigotine study investigator Arthur S. Walters, MD, Professor, Department of Neuroscience, Seton Hall University School of Graduate Medical Education, and Director of the Center for Sleep Disorders Treatment, Research and Education at the New Jersey Neuroscience Institute at JFK Medical Center. "These study results showed that rotigotine significantly improved symptoms of restless legs syndrome throughout the six month trial period."

In July 2007 Neupro(R) was launched in the United States for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. In Europe, Neupro(R) is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy and as adjunctive therapy with levodopa in advanced-stage Parkinson's disease.

About Restless Legs Syndrome:

Restless legs syndrome (RLS) is a chronic neurological disorder that affects between three and ten percent of the population. It is characterized by unpleasant feelings in the legs and an irresistible urge to move in order to relieve the discomfort. RLS sensations are frequently described as tingling, burning, tugging, gnawing and pulling. The exact cause of RLS is not known; however, recent clinical research has linked certain genes to RLS, suggesting that the disorder is biologically based.

Symptoms of RLS typically appear during periods of rest and inactivity, particularly in the evenings and at night. This can make it difficult to fall asleep and stay asleep, thus preventing recuperative sleep and often leading to daytime fatigue and reduced alertness. While RLS symptoms are generally most pronounced in the evening and while at rest, other periods of inactivity, such as long flights, car trips and sitting in a movie theater, can also trigger symptoms.

About Neupro(R) in the USA:

In the USA, Neupro(R) is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy. Neupro(R) delivers the dopamine agonist, rotigotine, directly from a patch into the bloodstream, through the skin and offers stable, continuous delivery of rotigotine 24 hours-a-day. Rotigotine is a drug that mimics dopamine, a chemical messenger that transmits impulses between nerve cells in the brain to produce smooth, coordinated movement. Neupro(R) offers once-daily dosing and a good tolerability profile.

Important Safety Information

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 with 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 (greater than or equal to 5%) 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 http://www.neupro.com.

About UCB

UCB, Brussels, Belgium (http://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 around 12,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZPHARMA (Monheim, Germany) is a member of the UCB Group.

Forward looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.


'/>"/>
SOURCE UCB
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinsons Disease
2. Claim Filed Against the Company and Nine Other Defendants in the Haifa Magistrates Court
3. First Nationwide Class Action Filed on Behalf of Consumers Who Purchased Topps E. Coli Contaminated Ground Beef
4. First Nationwide Class Action Filed Against ConAgra on Behalf of Consumers Who Purchased or Ingested Salmonella Contaminated Pot Pies
5. Federal Charges Filed Against Community Medical Centers Management
6. Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.
7. Shareholder Class Action Filed Against Aetna Inc. by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
8. Another Medtronic Sprint Fidelis Lead Lawsuit is Filed in Federal District Court
9. Class Action Lawsuit Filed Against 15 California Nursing Homes
10. New treatment effective in counteracting cocaine-induced symptoms
11. New treatment boosts muscle function in myasthenia gravis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Cary, North Carolina (PRWEB) , ... June 26, 2016 , ... ... the release of a new product that was developed to enhance the health of ... harvested for centuries. , The two main herbs in the PawPaws Cat Kidney ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... ... , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors ... Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green ... hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... , June 26, 2016 ... care operating models within the health care industry is ... financial efficiency , Deloitte offers a suite of ... business issues impacting efficient cost optimization: labor resource analysis, ... These services facilitate better outcomes and better economics ...
(Date:6/24/2016)... , June 24, 2016 ... has announced the addition of the " Global ... This report ... provides an updated review, including its applications in various ... total market, which includes three main industries: pharmaceutical and ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
Breaking Medicine Technology: