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INDIANAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic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:7/30/2015)... 2015 Edwards Lifesciences Corporation (NYSE: EW ), ... hemodynamic monitoring, today announced that Robert A. Ingram ... "Bob is an ardent champion for innovation in the lifesciences ... him on Edwards, board as we pursue our focused innovation ... CEO.  "Bob has provided a valuable perspective to our board, ...
(Date:7/30/2015)... SAN DIEGO , July 30, 2015 ... announced it has signed a definitive agreement ... provider of non-invasive ventilation and sleep-disordered breathing ... strong clinical, innovation and market reputation in China, combined with ResMed,s global leadership ... of people in China ...
(Date:7/30/2015)... 2015  ResMed Inc. (NYSE: RMD ) today ...  Revenue for the quarter was $453.1 million, a 9 ... 2014 (a 17 percent increase on a constant currency ... quarter ended June 30, 2014.  Diluted earnings per share ... ended June 30, 2014.  The results ...
Breaking Medicine Technology:ResMed Invests in High-Growth Chinese Sleep and Respiratory Care Market with Curative Medical 2ResMed Invests in High-Growth Chinese Sleep and Respiratory Care Market with Curative Medical 3ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 2ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 3ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 4ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 5ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 6ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 7ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 8ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 9ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 10ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 11ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 12ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 13ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 14ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 15ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 16
(Date:7/31/2015)... ... July 31, 2015 , ... Patients with higher levels of a ... published today in Nature Communications and led by researchers from the Icahn School of ... in the gene RTN1 led to greater production of the related RNT1 protein, which ...
(Date:7/31/2015)... ... ... Indosoft, Inc., is pleased to announce a major update to its agent ... center ACD system for Asterisk-based call centers . The new features make it ... the agent only when wanted, and allows for validation of data as the agent ...
(Date:7/31/2015)... ... 31, 2015 , ... According to WFLA on July 16th, Sarasota ... and eventual overdoses. Thricefold deaths have held steady over the last “couple of months” ... heroin epidemic, which was spurred by the crackdown of prescription painkillers. Many users who ...
(Date:7/31/2015)... ... July 31, 2015 , ... ... Medicine Practice, and Hospital Medicine Practice, is pleased to announce that it has ... mobile application format available on iPhones, iPads, and Android smartphones and tablets. ...
(Date:7/31/2015)... ... July 31, 2015 , ... An article ... NBC talked about a woman’s unfortunate experience having cosmetic skin procedures done by ... which resulted in blistering, swelling, bruising, and pain. This woman’s experience is only ...
Breaking Medicine News(10 mins):Health News:Mount Sinai Researchers Find Key Gene Drives Kidney Disease Severity 2Health News:Mount Sinai Researchers Find Key Gene Drives Kidney Disease Severity 3Health News:Q-Suite 5.9 Adds Validation Tools to Call Center Software Agent Screen 2Health News:Sarasota Sufferers Increased Heroin Overdoses and Deaths 2Health News:Sarasota Sufferers Increased Heroin Overdoses and Deaths 3Health News:EB Medicine Launches Mobile Application for Pediatric Emergency Medicine 2Health News:EB Medicine Launches Mobile Application for Pediatric Emergency Medicine 3Health News:Dermatologists Discuss Rise in Unqualified Practitioners of Cosmetic Dermatology 2Health News:Dermatologists Discuss Rise in Unqualified Practitioners of Cosmetic Dermatology 3
... to Raise $260,000 for ORBIS Children,s Eye Care Project ... ... Nyan and Lehka Pendyala, ages 8 and 6,will launch a kid-inspired and ... childhood blindness. Their,ultimate goal is to raise $260,000 for a specialized pediatric ...
... Human Health Effects of Fruit and Vegetables (FAV) is ... from October 9 till 13 in Houston, TX. ... & bridge the communication gap between the agricultural sciences, ... is unique since scientists, students, industry, commodity groups and ...
... 9 Nurse Savvy Research Group is,an exciting ... is an online medical information service established to,provide ... to which,doctors they would choose for a variety ... The data gathered for the website will be,obtained ...
... ... Saudi Arabia, SOMERSET, N.J., Oct. ... AWT International, Inc.,has opened new sales offices in Saudi Arabia. ... healthcare industry. The Company has hired 2 highly experienced executives ...
... Two UT Southwestern Medical Center researchers a distinguished ... elected to the Institute of Medicine, a component of ... Luis Parada, professor and chairman of developmental biology, and ... among 65 new national members and four foreign associates ...
... DIEGO, Oct. 9 Many Americans are obsessed with,staying ... about being,mentally fit. More Americans are becoming aware of ... where knowledge, intelligence, and quick,wits are rewarded. Being mentally ... effectively train your brain have been lacking,until recently. ...
Cached Medicine News:Health News:Elementary School Students to Launch 'Kids for Sight' Campaign, to Inspire Other Kids to Pay it Forward 2Health News:Elementary School Students to Launch 'Kids for Sight' Campaign, to Inspire Other Kids to Pay it Forward 3Health News:Nursesavvy.com Promoting Quality Healthcare for Everyone 2Health News:AWT, Inc. Continues Rapid Expansion in Middle East 2Health News:AWT, Inc. Continues Rapid Expansion in Middle East 3Health News:2 UT Southwestern researchers elected to National Academy of Sciences' Institute of Medicine 2Health News:2 UT Southwestern researchers elected to National Academy of Sciences' Institute of Medicine 3Health News:Online Game from BrainGrade Can Raise Brain I.Q. 2
Touch-Trol Pediatric Suction Catheter Mini-Tray...
SAFE-T-VAC Coil Packed Suction Catheters Kits, Sterile without Solution...
Sterile, Coil Packed Suction Catheter Mini Tray with (2) Walleted SAFESKIN PURPLE NITRILE Latex-Free Exam Gloves. 14 Fr., DeLee Tip, with Drape...
Clear plastic sleeve envelopes a plastic suction catheter. Sleeve slides over exudate to reduce potential clinician contact....
Medicine Products: