Navigation Links
Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
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 adjunctive therapy with levodopa in

adult patients with advanced-stage Parkinson's disease

ATLANTA, Dec. 13 /PRNewswire/ -- UCB announced today that the supplemental New Drug Application (sNDA) for the use of Neupro(R) as adjunctive therapy with levodopa in adult patients with advanced-stage Parkinson's disease has been accepted for filing by the U.S. Food and Drug Administration (FDA).

The FDA has already approved Neupro(R) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease and the drug has been commercially available in the United States since July 2007.

"We are excited that patients with all stages of Parkinson's disease may soon benefit from Neupro(R)'s 24-hour continuous drug delivery," said Troy Cox, President CNS Operations, UCB.

The sNDA is based on efficacy and safety data in more than 670 patients with advanced-stage Parkinson's disease who were treated with rotigotine in three double-blind, placebo-controlled clinical trials. These studies demonstrated that rotigotine, as adjunctive therapy to levodopa in patients with advanced-stage Parkinson's disease, showed clinically relevant reductions in "off" time (periods where the effectiveness of medications wear off and Parkinson's symptoms return) and favorable increases in "on" time without troublesome dyskinesia (fragmented or jerky movements). The most frequently-reported adverse events in rotigotine clinical trials included application site reactions, nausea, vomiting, dizziness, somnolence and dyskinesia.

"As these clinical studies have shown, continuous delivery of rotigotine in a transdermal form can improve control of 'off' time in advanced-stage Parkinson's patients throughout the day and night. Once-daily dosing may improve compl
'/>"/>

SOURCE UCB
Copyright©2007 PR Newswire.
All rights reserved

2

GOOD

Page: 1 2 3 4

Related medicine news :

1. Claim Filed Against the Company and Nine Other Defendants in the Haifa Magistrates Court
2. First Nationwide Class Action Filed on Behalf of Consumers Who Purchased Topps E. Coli Contaminated Ground Beef
3. First Nationwide Class Action Filed Against ConAgra on Behalf of Consumers Who Purchased or Ingested Salmonella Contaminated Pot Pies
4. Federal Charges Filed Against Community Medical Centers Management
5. Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.
6. Shareholder Class Action Filed Against Aetna Inc. by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
7. Another Medtronic Sprint Fidelis Lead Lawsuit is Filed in Federal District Court
8. Class Action Lawsuit Filed Against 15 California Nursing Homes
9. New treatment effective in counteracting cocaine-induced symptoms
10. New treatment boosts muscle function in myasthenia gravis
11. Broad-based group of physicians calls for improvement in stroke treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... The India Network Foundation, a ... insurance, announces a new pre-existing condition coverage plan: ... the years, India Network members have requested a ... maximums, and duration. The Platinum Comprehensive Plan is ... the valuable coverage and benefits of a PPO ...
(Date:5/20/2013)... Heritage Woods of Gurnee , ... Illinois, is hosting Breakfast and Bingo at 8:30 a.m. ... located at 3775 Grand Ave. in Gurnee, Illinois, serves ... who need some help to maintain their independence. , ... of bingo," says Tammy Temaner-Rosas, Director of Marketing for ...
(Date:5/20/2013)... May 21, 2013 For the ... the Best of Frederick Award in the Professional ... Association (USCA). , The USCA "Best of Local ... the country. Each year, the USCA identifies companies ... in their local community and business category. These ...
(Date:5/20/2013)... May 20, 2013 Recent environmental ... of using green and sustainable inputs in packaging ... implemented regulations to promote the use of sustainable ... and Labelling Services industry . “Tax subsidies and ... says IBISWorld industry analyst Deonta Smith. “For example, ...
(Date:5/20/2013)... Dr. Robert Mokbel is one of the ... the Laser Assisted New Attachment Procedure, a laser ... disease. LANAP may help many Fountain Valley residents who ... the jawbone support necessary to support dental implants. , ... tartar in the mouth. Daily oral hygiene activities typically ...
Breaking Medicine News(10 mins):Health News:Indian Network announces Platinum Comprehensive Visitor Health Insurance Plan with Pre-existing Condition Choices for Visitors on Short Term Trip to the United States 2Health News:Indian Network announces Platinum Comprehensive Visitor Health Insurance Plan with Pre-existing Condition Choices for Visitors on Short Term Trip to the United States 3Health News:Heritage Woods of Gurnee Affordable Assisted Living Community to Host Breakfast and Bingo 2Health News:A2LA Receives 2013 Best of Frederick Award 2Health News:Packaging and Labelling Services in Canada Industry Market Research Report Now Available from IBISWorld 2Health News:Packaging and Labelling Services in Canada Industry Market Research Report Now Available from IBISWorld 3Health News:Fountain Valley, Ca Gum Disease Patients with Missing Teeth Can Now Receive Laser Gum Surgery from Dr. Robert Mokbel for Success with Dental Implants 2
... of Minnesota scientists anti-angiogenics are compounds that are very ... molecules which cut of the blood supply to the ... The study results appear in the Journal of the ... drugs that increases the potential for good, effective treatment ...
... monitoring data human welfare, spread of infectious disease and food ... to acquire the proper balance between ecological systems//. ... has used a satellite imagery to enable the study of ... effect on human health and food security. ,Doug ...
... of Kansas State University, Doug Goodin, makes use of ... and land cover //changes on human health and food ... sensing with other types of data, to monitor and ... scientists he recently discussed this subject at the workshop, ...
... to zero in (on) the modalities of a drug, capable ... Clinical trials on animal models have revealed the capacity of ... in charge of energy production., ,'Many drugs block ... Glick, who is the Werner E. Bachmann Collegiate Professor of ...
... NHS can be freed from its’ problems, if privatization ... are implemented. // It is amply clear that the ... worse for the deprived and under privileged sections of ... low morale among Doctors and NHS staff. Quality of ...
... BARACLUDE? (entecavir) for the treatment of chronic hepatitis B ... General of India. ,BARACLUDE (entecavir) is indicated ... in adults with evidence of active viral replication and ... or AST) or histologically active disease. ,BARACLUDE? ...
Cached Medicine News:Health News:Ecological Changes affects human health, food security 2Health News:Satellite Imagery to monitor the Social Impact Of Geographical Changes 2Health News:Autoimmune disorders studied in detail by U-M researchers. 2Health News:India Approves Baraclude? (entecavir) For ,Treatment Of Chronic HEPATITIS B 2
(Date:5/21/2013)... 2013 Reportlinker.com announces that a ... its catalogue:   ... Medical Devices in the US Market ... Changing Regulatory and Reimbursement Scenario for ...   Summary ...
(Date:5/21/2013)... , May 21, 2013 Ceregene, ... secondary analysis of its double-blind, randomized, controlled Phase ... a gene therapy product designed to deliver the ... analysis identified a more robust response to CERE-120 ... to treatment relative to those diagnosed 10 years ...
(Date:5/21/2013)... Calif. , May 21, 2013 /PRNewswire/ ... ), a specialty pharmaceutical company focused on ... for the treatment of acute and breakthrough ... in a placebo-controlled Phase 3 study of ... analgesia) System (NanoTab System), the primary efficacy ...
Breaking Medicine Technology:Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market 2Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market 3Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market 4Ceregene Reports Additional Efficacy Data From Parkinson's Disease Phase 2b Study 2Ceregene Reports Additional Efficacy Data From Parkinson's Disease Phase 2b Study 3Ceregene Reports Additional Efficacy Data From Parkinson's Disease Phase 2b Study 4Ceregene Reports Additional Efficacy Data From Parkinson's Disease Phase 2b Study 5Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 2Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 3Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 4Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 5Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 6Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 7Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 8Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 9Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain 10
... RA Signs and Symptoms Compared to Placebo, ... (Nasdaq: TRBN ) today announced preliminary ... double-blind, placebo-controlled, multicenter,clinical trial of its TRU-015 ... indicated that Trubion,s TRU-015 product candidate, at,well-tolerated ...
... Calif., Sept. 10 Peregrine,Pharmaceuticals, Inc. (Nasdaq: ... antibodies for the treatment of cancer and,hepatitis C ... submitted a,clinical protocol with the Drug Controller General ... safety and efficacy trial of bavituximab in combination,with ...
Cached Medicine Technology:Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis 2Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis 3Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis 4Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis 5Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer 2Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer 3Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer 4
Liquichek Autoimmune Controls are individual controls for monitoring the performance of autoimmune assays....
Liquichek Autoimmune Controls are individual controls for monitoring the performance of autoimmune assays....
Liquichek Autoimmune Controls are individual controls for monitoring the performance of autoimmune assays....
... next generation system for ... the power of automation ... laboratory. As many as ... loaded and analyzed in ...
Medicine Products: