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INDIANAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic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:8/29/2014)... Aug. 29, 2014 Research and Markets ... Orthopedic Instrument Industry Report, 2014-2017" report to their ... and rising proportion of reimbursement for medical expenses, the ... with its scale presenting a CAGR of 19.2% during ... three product segments of orthopedic instruments in ...
(Date:8/29/2014)... According to a new ... type (SFE, Cold Pressed, Organic Solvent, & Others), and ... Fragrance, & Others) - Global Trends & Forecast ... the Amaranth Seed Oil Market with an analysis ... of value. The Amaranth Seed Oil Market size ...
(Date:8/29/2014)... SILVER SPRING, Md. , Aug. 29, 2014 /PRNewswire/ ... today that the U.S. District Court for the District ... in its favor in the company,s case against Sandoz, ... opinion, Judge Peter Sheridan ruled that U.S. ... Sandoz, Inc., and enjoined Sandoz from marketing its generic ...
Breaking Medicine Technology:China Orthopedic Instrument Industry Report, 2014-2017 2Amaranth Seed Oil Market worth $700.6 Million by 2019 2Amaranth Seed Oil Market worth $700.6 Million by 2019 3Amaranth Seed Oil Market worth $700.6 Million by 2019 4District Court Decision Received In Remodulin Patent Case 2
... Aug. 10, 2011 GNS Healthcare, Inc., (GNS) ... personalized medicine to improve human health, today announced ... Bristol-Myers Squibb Company (NYSE: BMY ) ... and biomarkers in the area of immuno-inflammation.  Utilizing ...
... Ardea Biosciences, Inc. (Nasdaq: RDEA ) announced today ... will present at the Wedbush Securities 2011 Life Sciences Management ... on Tuesday, August 16, 2011. This presentation ... Relations section of Ardea,s website at www.ardeabio.com . Please ...
Cached Medicine Technology:GNS Healthcare Announces Collaboration With Bristol-Myers Squibb 2Ardea Biosciences to Present at Wedbush Securities Life Sciences Conference 2
(Date:8/29/2014)... of clinical trials based on administering antidepressants for ... that more trials are needed to determine whether ... on a regular basis., Dr. Ian Gilron, a ... the Department of Anesthesiology, and his team of ... the use of antidepressants for pain relief post-surgery ...
(Date:8/29/2014)... 2, 2014) A team of scientists from the ... breakthrough discovery of a process to expand production of ... could have implications that extend beyond cancer, including treatments ... In an article published Aug. 29 in ... Gates Center for Regenerative Medicine and Stem Cell Biology ...
(Date:8/29/2014)... 29, 2014, 2 PM US Eastern Time)The current ... inject antibodies, commonly produced in animals, to neutralize ... from safety to difficulties in developing, producing and ... New research led by Charles Shoemaker, Ph.D., professor ... Health at the Cummings School of Veterinary Medicine ...
(Date:8/29/2014)... new study from the research group of Dr. John Lewis ... Health Research Institute (London, ON) has confirmed that "invadopodia" play ... published in Cell Reports , shows preventing these tentacle-like ... , Roughly 2 in 5 Canadians will develop cancer ... die of the disease. In 2014, it,s estimated that nine ...
(Date:8/29/2014)... (PRWEB) August 30, 2014 Top10inaction, a ... web conference providers in the online service industry for ... were global leaders Webex, GotoMeeting and Infinite. , With ... users have to determine which provider is ideally a ... conference businesses search for compelling consumer goods and services ...
Breaking Medicine News(10 mins):Health News:Antidepressants show potential for postoperative pain 2Health News:CU scientists' discovery could lead to new cancer treatment 2Health News:Mice study shows efficacy of new gene therapy approach for toxin exposures 2Health News:Preventing cancer from forming 'tentacles' stops dangerous spread 2Health News:Top10InAction Reveals Best Web Conference Providers 2
... of Medicine (BUSM), Management (SMG) and Law (LAW), along ... that public-sector research has had a more immediate effect ... findings, which appear as a Special Article in the ... of Medicine , have economic and policy implications. ...
... HealthDay Reporter , WEDNESDAY, Feb. 9 (HealthDay ... cell genome revealed never-before-seen changes in DNA that may ... mapping the full genetic blueprint of the tumor, researchers ... of more targeted drugs and a better understanding of ...
... investing in public parks and recreation sites may be ... healthcare system, according to Penn State researchers. Investments in ... health and fitness, say Geof Godbey, professor emeritus of ... and parks management. "There is a strong relationship between ...
... heart disease, cancers, HIV and other diseases quickly and ... microsponges are an essential component of Rice University,s Programmable ... in the journal Small . The ... and Chemistry, and his colleagues at Rice,s BioScience Research ...
... Family Physicians demonstrates that vulvar cancer occurs most frequently in women ... with vulvar cancer are age 70 or older, and the rate ... by 75 years of age. , A team of researchers headed ... in Women,s Oncology at Women & Infants Hospital of Rhode Island, ...
... Poor memory and problems with other mental skills may be early ... Researchers gave a word recall memory test to 17,851 people, ... measure the brain,s executive functioning skills. The participants, who were aged ... stroke, were then contacted twice a year for up to 4.5 ...
Cached Medicine News:Health News:Researchers find public sector research responsible for many new drug discoveries 2Health News:Researchers find public sector research responsible for many new drug discoveries 3Health News:First Look at Prostate Cancer Genome Yields Insights 2Health News:First Look at Prostate Cancer Genome Yields Insights 3Health News:Key to better health care may be a walk in the park 2Health News:Microsponges from seaweed may save lives 2Health News:Microsponges from seaweed may save lives 3Health News:Researchers: Elderly patients 4 times more likely to die from treatment complications 2Health News:Could Poor Memory Signal Raised Stroke Risk? 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: