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:2/13/2016)... ... February 13, 2016 , ... ... Society (INS) states that vein visualization technology should be used to ensure patient ... around the world, the INS Standards mandate the use of vein visualization technology ...
(Date:2/13/2016)... ... 13, 2016 , ... When an Au Pair comes all the way around the ... in for and they are often worried things won’t go well. More often than not, ... year’s Au Pair of the Year winner’s all commented how their Au Pairs have become ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi ... Management Solution Providers list for its expertise in eClinical Solutions. DDi has built ... serve the technology needs of global clients. DDi provides smarter technology for Clinical ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Mystic Buddha Publishing ... in Blue SKies Buddha, the biography of Rama - Dr. Frederick Lenz. ... story, the love of a Buddhist teacher for teaching and helping others. Valentine’s ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... initiative—the Siemens Foundation-PATH Ingenuity Fellowships—to develop the advanced skills needed to introduce ... from U.S. universities who will draw from Siemens’ deep knowledge of product ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... , Maharashtra, February 12, 2016 ... Market research report titled Chronic Inflammation Global Clinical ... a snapshot of the global clinical trials landscape ... clinical trials by Region, Country (G7 & E7), ... point status and reviews top companies involved and ...
(Date:2/11/2016)... Feb. 11, 2016 Stem cells are primitive ... by self-renewal and the capacity to differentiate into mature ... discovery, as the first mouse embryonic stem cells were ... until 1995 that the first culturing of embryonic stem ... were not produced until 2006 As a result of ...
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016  Kindred ... focused on saving and improving the lives of pets, ... Technical Section of the New Animal Drug Application (NADA) ... the pivotal field study (KB0120) of Zimeta for the ... by the Company. --> ...
Breaking Medicine Technology: