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INDIANAPOLIS, Nov. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic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:10/1/2014)... , Oct. 1, 2014 Trovagene, Inc., ... announced today that Eli Diamond , MD, ... Center (MSK), presented clinical data from an ongoing ... monitoring platform for the determination of oncogene mutational ... biopsy.  The results were presented to both treating ...
(Date:10/1/2014)... MARCOS, Texas , Oct. 1, 2014 /PRNewswire/ ... it is scaling volume production of photoactive quantum ... power technologies . While offering numerous advantages for ... of producing large quantities of quantum dots with ... until now kept them from commercial utilization and ...
(Date:10/1/2014)... Oct. 1, 2014  CVS Health is thanking its ... role in changing the way health care is delivered ... the Company,s retail pharmacies, mail service pharmacies and specialty ... our company name to CVS Health to reflect our ... the innovations needed to shape the future of health," ...
Breaking Medicine Technology:Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium 2Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium 3Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium 4Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 2Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 3CVS Health Thanking its Pharmacists during American Pharmacists Month for Helping People on Their Path to Better Health 2CVS Health Thanking its Pharmacists during American Pharmacists Month for Helping People on Their Path to Better Health 3
... 2012 i-Path Media LLC, a pharmaceutical marketing ... with their clients, received national certification as a ... Organization-New York Certification Committee, a regional certifying partner ... WBENC,s national standard of certification is ...
... Jan. 16, 2012  Palatin Technologies, Inc. (NYSE Amex: ... targeted, receptor-specific peptide therapeutics for the treatment of ... potential, today announced that Dr. Carl Spana, President ... Noble Financial Capital Markets, Eighth Annual Equity Conference.  ...
Cached Medicine Technology:Palatin Technologies to Present at BOCEMb, Noble Financial Capital Markets' Eighth Annual Equity Conference 2
(Date:10/1/2014)... Farmington Company today announced it has ... visual identity helping brokers, consultants and companies to ... create greater benefit communication synergies. They unveiled a ... customers to better leverage Farmington Company’s industry-tested experience ... the rebrand is the refreshed tagline: For the ...
(Date:10/1/2014)... Beverly Hills licensed Clinical Psychologist and nationally ... years of private practice in her Beverly Hills office ... greater joy and fulfillment in their relationships. Dr. Mojas ... suggestions for anyone who suspects they are in a ... or not, it’s not always easy to know when ...
(Date:10/1/2014)... NJ (PRWEB) October 01, 2014 Diet Doc ... their intentions to lose weight and their dieting attempts could ... fatty foods. Including hormone diet treatments into their ... allows patients to see fast and effective weight loss results, ... begin forming healthy habits to maintain their weight for the ...
(Date:10/1/2014)... Scientists at the University of Western Australia ... system proteins has the power to knock out mesothelioma ... the new study on their website. Click here ... the UWA School of Pathology and Laboratory Medicine administered ... mesothelioma with promising results. , “A timed triple ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 Nordic ... benefit a very special cause. The campaign—“Buy One ... for Paws for Veterans, a nonprofit organization that ... also rescuing shelter dogs that would otherwise face ... featured products will support monthly donations of Nordic ...
Breaking Medicine News(10 mins):Health News:Farmington Company Launches Rebrand and New Positioning 2Health News:Prominent Beverly Hills Psychologist Dr. Kathleen Mojas Celebrating 20 Years in Private Practice Identifies Common Warning Signs That You May Be In a Toxic Relationship. 2Health News:Prominent Beverly Hills Psychologist Dr. Kathleen Mojas Celebrating 20 Years in Private Practice Identifies Common Warning Signs That You May Be In a Toxic Relationship. 3Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 2Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 3Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 4Health News:New Mesothelioma Study Says Mice Cured by Immuntherapy “Cocktail”, Reports Surviving Mesothelioma 2Health News:Nordic Naturals® Inspires Support for Paws for Veterans -- ‘Buy One Bottle. Help Two Heroes.’ Initiative Kicks Off October 1 2
... , ATLANTA and PHILADELPHIA, ... Technology, collaborating with pediatric cardiologists and surgeons at The ... virtual surgery that allows heart surgeons to view the ... cardiac magnetic resonance images of a patient,s specific anatomy, ...
... , , NIAGARA ... Pacific Corporation,s (Nasdaq: APFC ) wholly-owned in-space propulsion ... monopropellant engines, with a 30+ year history of successful space ... NASA,s Lunar Reconnaissance Orbiter (LRO) and Lunar Crater Observation and ...
... ... Technology for its Passport Assets Application Enabling Its Customers to Improve System Efficiency, Improve ... ... ASAP Systems today announced the release of its mobile RFID technology for their ...
... , , , ... device franchise, announced today the launch of eMed-Alert, a next-generation personal assistance ... in an emergency. With more than 11 million Americans age 65 ... their independence. , , "As baby ...
... , SOMERSET, N.J., Aug. 11 ... healthcare and administrative staffing services, will announce its third quarter financial results ... before the market opens. TeamStaff will host a conference call for ... Interested parties may participate in the call by dialing (877) ...
... PRINCETON, N.J., Aug. 11 Ranbaxy Pharmaceuticals Inc. (RPI), a ... that RLL has received final approval from the U.S. Food ... 25 mg (base), and 50 mg (base). The Office ... the Ranbaxy formulations to be bioequivalent and have the same ...
Cached Medicine News:Health News:MRI Simulation of Blood Flow Helps Plan Child's Heart Surgery 2Health News:MRI Simulation of Blood Flow Helps Plan Child's Heart Surgery 3Health News:MRI Simulation of Blood Flow Helps Plan Child's Heart Surgery 4Health News:MRI Simulation of Blood Flow Helps Plan Child's Heart Surgery 5Health News:AMPAC-ISP Engines Support Key NASA Lunar Missions 2Health News:ASAP Systems Introduces Mobile RFID Technology for its Passport Assets Application Enabling Increase Asset Management Flexibility 2Health News:ASAP Systems Introduces Mobile RFID Technology for its Passport Assets Application Enabling Increase Asset Management Flexibility 3Health News:World's First Emergency Medical Device Franchise Launches eMed-Alert 2Health News:World's First Emergency Medical Device Franchise Launches eMed-Alert 3Health News:TeamStaff, Inc. To Announce Third Quarter Results 2Health News:TeamStaff, Inc. To Announce Third Quarter Results 3Health News:Ranbaxy Receives Final Approval To Market Sumatriptan Succinate Tablets 2
... testing your blood glucose regularly, you want ... possible. Conventional spring-loaded lancet systems often penetrate ... cause painful dilation or tearing of skin ... a precise, linear action that provides greater ...
... Focus from Thermo Labsystems was designed specifically ... Advanced features such as the new fast ... on microvolumes help to define this as ... The new interchangeable handle plate offers a ...
This CLS number is a new product number, created to easily match Cornings product number. If showing no availability yet, please order under the old Sigma-Aldrich number (Z71,410-0) or contact custom...
... models cover the range from 2ul to 5000ul. ... Volume lock design prevents inadvertent volume change. ... Whole pipette is autoclavable at 121C(250F). ... polypropylene. Suitable for one-handed operation. Auto ...
Medicine Products: