Navigation Links
Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain
Date:11/28/2008

INDIANAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain. Lilly plans to resubmit the application in the first half of 2009, adding data from a recently completed positive study in chronic osteoarthritis pain of the knee.

The decision does not affect duloxetine's FDA-approved indications for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.

Lilly submitted the chronic pain application in the second quarter of 2008 based primarily on outcomes of three clinical trials: one positive study in chronic osteoarthritis pain of the knee(i) and two studies(ii,iii), -- one positive and one that is supportive but didn't meet its primary endpoint -- in chronic low back pain. In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.

"This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application," said John Hayes, M.D., a Lilly Research Laboratories vice president at Lilly.

Chronic pain affects more than 50 million Americans(iv) and pain is a major cause of work absenteeism, underemployment and unemployment.(v,vi,vii,viii)

About Duloxetine

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on preclinical studies, Duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is bel
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
2. Lilly and Deciphera Pharmaceuticals Announce Licensing and Collaboration Agreement
3. Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimers Disease Compound
4. Insulin Analogues From Novo Nordisk, Eli Lilly and Sanofi-Aventis Will Drive Growth in the Type 1 Diabetes Drug Market
5. Phase II Data on Lillys Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimers Disease
6. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
7. Lilly and TransPharma Medical Announce Licensing and Development Agreement
8. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
9. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
10. Lilly Launches Its First Phase III Trial for Treatment of Alzheimers Disease
11. Lilly and Transition Therapeutics Announce Licensing and Collaboration Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Jan. 15, 2014  Manufacturers, suppliers and distributors of ... to protect their most important business assets, intellectual ... ) Because of the highly-competitive nature ... one of the most litigious industry sectors of ...
(Date:1/15/2014)... Jan. 15, 2014 MultiCell Technologies, Inc. (OTC Bulletin ... provisional patent application concerning composition of matter, biological targets, ... tumor cell death.  This patent application ... stranded RNA molecules (VSRNAs) which interfere with the basic ...
(Date:1/15/2014)... Jan. 15, 2014  According to Millennium Research Group ... intelligence, the United States ... markets will expand moderately through 2022, with embolization ... particular, increasing interest in drug-eluting beads (DEBs) and ...
Breaking Medicine Technology:Intellectual Property Insurance for Medical-related Products and Services 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3
(Date:4/22/2014)... a new RAND study concludes that U.S. policy makers ... device makers to develop products that produce more value. ... use, a new study suggests the study identifies options ... in the first place. The aim is to help ... health as possible and to ensure that costlier advances ...
(Date:4/22/2014)... of all patients diagnosed with non-small cell lung cancer ... this high percentage, these elderly patients are not well ... data has made it difficult to reach evidence based ... the Elderly Task Force and Lung Cancer Group along ... an expert opinion on managing treatment for elderly patients ...
(Date:4/22/2014)... but their total brain size suggests they have ... squirrel, according to a new study of 36 ... to zebra finches. , Scientists at Duke University, ... other research institutions collaborated on this first large-scale ... the study as the ability to inhibit powerful ...
(Date:4/22/2014)... parents are more likely to have a child who ... parents. A recent study from researchers from the Drexel ... Institute in Sweden provides more insight into how the ... fathers, ages, and found that the risk of having ... larger for older parents., In the study, published in ...
(Date:4/22/2014)... a sleep disorder that causes people to act out ... diseases like Parkinson,s and Alzheimer,s. , "Rapid-eye-movement sleep ... also a critical warning sign of neurodegeneration that can ... author Dr. John Peever. In fact, as many as ... will develop a brain disease." , As the name ...
Breaking Medicine News(10 mins):Health News:US medical innovation needs smarter incentives to cut health spending, study finds 2Health News:US medical innovation needs smarter incentives to cut health spending, study finds 3Health News:EORTC and SIOG update expert opinion on management of elderly patients with NSCLC 2Health News:Brain size matters when it comes to animal self-control 2Health News:Brain size matters when it comes to animal self-control 3Health News:Child's autism risk accelerates with mother's age over 30 2Health News:Child's autism risk accelerates with mother's age over 30 3
... Three X-Ray Rooms from Film to IDC Digital ... ... IDC (Imaging Dynamics Company,Ltd.) (TSX: IDL), the global leader in the ... Saratoga,Springs, New York has purchased IDC,s X2200, X1590, and X1600 Plus ...
... N.Y., April 7, 2008 Nutrition 21,Inc. (Nasdaq: ... help consumers manage blood sugar levels, improve cardiovascular,health, enhance ... H. Stenberg has been elected to the Company,s Board ... the founder and Chief Executive Officer of Iceland,Health, Inc. ...
... (April 7, 2008) The American Society of Cataract ... participate in a post-LASIK quality of life study with ... U.S. Food and Drug Administration (FDA), the National Eye ... ASCRS also announced that the ASCRS Foundation has ...
... laughter helps reduce body,s release of stress hormones , , ... laugh reduces the release of stress hormones that can ... new study. , The researchers, who previously had ... hormones, suggested that mirth may be a key to ...
... W.Va., April 7, 2008 ReBuilder,Medical Technologies, Inc. ... announced that the corporation is ready to grow ... public equity markets., (Logo: http://www.newscom.com/cgi-bin/prnh/20061128/REBUILDERLOGO ... company for a year and have experienced,the limitations ...
... 7, 2008 Edmond Medical Center and,ophthalmologists M. Andrew ... Eye Associates, will once again participate in the Mission,Cataract ... those who cannot afford to pay., Appointments can ... If the patient qualifies for the cataract surgery and ...
Cached Medicine News:Health News:Saratoga Hospital Purchases Three IDC DR Systems 2Health News:Saratoga Hospital Purchases Three IDC DR Systems 3Health News:Nutrition 21 Elects Mark H. Stenberg to Board of Directors 2Health News:ASCRS to participate in and co-fund study on post-lasik quality of life with US FDA 2Health News:ASCRS to participate in and co-fund study on post-lasik quality of life with US FDA 3Health News:Heard the One About How to Beat Tension? 2Health News:ReBuilder Medical Technologies, Inc. Seeks a Bigger and More Credible Equity Market - 'NASDAQ, here we come!' 2Health News:Edmond Medical Center to Provide Free Cataract Surgeries 2
Continuous rocking motion graphic display....
Two sided, 72 frame, acrylic eyewear tower with side mirrors and sign holder on top. Breaks down for easy shipping....
... maximum impact for the marketing of optical ... displaying frames allows your retail area to ... and eye-catching displays. The products are shown ... motivated. Removable holders. Variable number of frames ...
A pre-assembled, hexagonal, revolving tower display with two round 19.75" in diameter adjustable shelves. Enjoy 3.5 square feet of elegant shelf space for your products....
Medicine Products: