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INDIANAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic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:4/28/2015)... 28, 2015 Anteo Technologies is transforming ... tools developed with their patented Mix&Go™ Activation Reagent. ... helping to improve medical devices and in-vitro diagnostics, ... Increasingly complex multifactorial diagnosis of cancer and autoimmune ... is restricted to measure only a single ...
(Date:4/27/2015)... -- Techpool Bio-Pharma Co has experienced tremendous changes in the ... executive officer, transforming from a traditional private Chinese company to ... took office in 2011, he was the senior executive in ... Eisai, with more than 20 years successful management experience in ... Asia-Pacific region. "I chose Techpool because ...
(Date:4/27/2015)... 2015   Intarcia Therapeutics, Inc. today announced ... with an equity conversion option at a $5.5 billion ... accelerate the initiation of additional head-to-head comparative and switch ... type 2 diabetes therapies. In addition, proceeds from the ... to launch ITCA 650 in the United ...
Breaking Medicine Technology:Faster Detection of Disease: Anteo is Transforming The Way Scientists Work with Luminex(R) xMAP(R) 2Faster Detection of Disease: Anteo is Transforming The Way Scientists Work with Luminex(R) xMAP(R) 3Techpool Transforms Into International Player 2Techpool Transforms Into International Player 3Intarcia Therapeutics Closes Novel $225 Million Synthetic Royalty Financing With Equity Conversion Option At $5.5 Billion Valuation 2Intarcia Therapeutics Closes Novel $225 Million Synthetic Royalty Financing With Equity Conversion Option At $5.5 Billion Valuation 3
... company products from its distribution operations in Enfield, Connecticut on Sunday, March 14 .   , ... , , ... ... Lilly is working with the U.S. ...
... The latest advancement in facial contouring, the AccuLift™ procedure, was just featured on CBS, The Early Show .  New York physician Dr. Jon Turk ... ... , ... ...
Cached Medicine Technology:Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 2Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 3Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 4Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 5Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 6Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 7Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations 8'The AccuLift Phenomenon' Kicks off on CBS' The Early Show 2'The AccuLift Phenomenon' Kicks off on CBS' The Early Show 3
(Date:4/28/2015)... (PRWEB) April 28, 2015 MSA ... healthcare executive search, announced today that it has been ... Chief Operating Officer search for The Queen's ... , Reporting to QHS President & CEO Arthur A. ... will have operating responsibility for the Queen’s Medical Center ...
(Date:4/28/2015)... (PRWEB) April 28, 2015 New ... also require more of manufacturers, payers, pharmacists and ... field’s premier journal, is partnering with the National ... trade association dedicated solely to this developing field ... fill this growing need. , “This partnership creates ...
(Date:4/28/2015)... Hellen Chen, who is a bestselling author ... According to a study conducted by Washington University, ... 30 has increased by 20% while the number of unfaithful ... a report released this year from the Journal ... one or both spouses admit to infidelity, either physical or ...
(Date:4/28/2015)... (PRWEB) April 28, 2015 The buyer ... 2.9 out of 5, indicating a medium level of ... buyers and suppliers have equal power during negotiations. One ... Rather than purchasing a health insurance policy from an ... or Humana), buyers can choose to self-fund their own ...
(Date:4/28/2015)... OsteoRemedies®, LLC, Memphis, TN, offers the ... infected hip and knee arthroplasty. , ... pre-loaded spacer with Gentamicin Antibiotics, for consistent and ... Combined with a consistent process for polishing the ... for temporary use for up to 180 days. ...
Breaking Medicine News(10 mins):Health News:The Queen’s Health Systems Retains MSA Executive Search to Recruit Executive Vice President & Chief Operating Officer 2Health News:Specialty Pharmacy Times Partners with National Association of Specialty Pharmacy to Improve Care for Patients 2Health News:Specialty Pharmacy Times Partners with National Association of Specialty Pharmacy to Improve Care for Patients 3Health News:Specialty Pharmacy Times Partners with National Association of Specialty Pharmacy to Improve Care for Patients 4Health News:Why Do Some Good Women and Men End Up Breaking Others' Marriages? 2Health News:Why Do Some Good Women and Men End Up Breaking Others' Marriages? 3Health News:New Data for Group Health Insurance Procurement Category Market Research Report from IBISWorld 2Health News:New Data for Group Health Insurance Procurement Category Market Research Report from IBISWorld 3Health News:New Data for Group Health Insurance Procurement Category Market Research Report from IBISWorld 4
... Research to Replicate Insulin-Producing Function of Healthy Pancreas for ... Calif., March 31 A key step toward the ... diabetes has been achieved, according to new research published ... Therapeutics .Researchers at the University of California at ...
... Md., March 31 John Lawson Cullison, Jr., an artist ... or "new age art," lost his ability to paint due ... due to the degeneration in cartilage tissue and symptoms include: ... spurs and severe swelling. Pain management and joint replacement ...
... refractory patients recruited in trial;, ... complete efficacy data to be available in ... Life Sciences Inc. (TSX: BNC), a research-based, technology-driven ... completed recruitment in its initial Phase III registration ...
... Available for Women Suffering from InsomniaLOS ANGELES, March 31 ... more lasting and negative impact than a lost night,s ... take care of and the endless array of other ... afford to lose any sleep.(Photo: http://www.newscom.com/cgi-bin/prnh/20090331/NYFNSS01 )Unfortunately, ...
... in The Journal of Nursing Administration shows ... continuous vigilance monitoring is used on medical-surgical unit beds. ... President and CEO of Hoana Medical, Inc. "Using ... potential patient deterioration so they can respond appropriately. ...
... Provides Extensive Services & SupportSAN FRANCISCO, March 31 ... home support and recovery services has announced a new ... HomeStyle Services first opened its San Francisco office in ... people remain independent as they age or recover from ...
Cached Medicine News:Health News:Researchers Successfully Create Computer-Simulated Model for Evaluating Artificial Pancreas 2Health News:Researchers Successfully Create Computer-Simulated Model for Evaluating Artificial Pancreas 3Health News:Korean Stem Cells Allow Artist to Paint Again 2Health News:Bioniche Completes Recruitment in First Phase III Clinical Trial with Urocidin(TM) 2Health News:Bioniche Completes Recruitment in First Phase III Clinical Trial with Urocidin(TM) 3Health News:Tired of Sleepless Nights? 2Health News:Continuous Vigilance Monitoring Technology Benefits Nurses & Patients 2Health News:Nation's Largest Home Care Provider Welcomes New Management Team to San Francisco Office 2
Blunt cannula for injection or aspiration of fluid. Thinwall cannula allows high flow rate. Blunt tip is smooth all around for easy insertion. Luer lock hub for easy, secure connection to a backflus...
PLX Series Sealed CO2 OEM Lasers....
... cost-effective line of compact CO2 systems combines ... an extremely accurate laser beam, as well ... especially advantageous for small operating theatres and ... Use of special contact tips and accessories ...
... NovaPulse 20-watt CO2 laser is ideal for ... flexible fiber delivery system, it combines the ... a familiar scalpel-like feel. The Novapulse system ... short pauses during which tissue is allowed ...
Medicine Products: