Navigation Links
Cadence Pharmaceuticals Announces FDA Approval of OFIRMEV™ (acetaminophen) injection for the Management of Pain and Fever
Date:11/2/2010

al medication can't be used."  

Clinical Trial Results Supporting FDA Approval

The FDA approval of OFIRMEV was based on data from clinical trials in which a total of 1020 adult and 355 pediatric patients received IV acetaminophen. These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the treatment of pain, and one study evaluating OFIRMEV in the treatment of fever. In a study of 101 orthopedic patients undergoing hip or knee replacement surgery, OFIRMEV 1000 mg every six hours was statistically superior to placebo for the reduction of pain intensity over 24 hours (p<0.01) with significantly reduced morphine consumption (33% over 24 hours, p<0.01).  In a second study of 244 patients undergoing abdominal laparoscopic surgery, OFIRMEV 1000 mg every six hours, or 650 mg every four hours, demonstrated a significant reduction in pain intensity over 24 hours compared to placebo (p<0.02).

In a study of adult volunteers with induced fever, a single dose of OFIRMEV 1000 mg demonstrated a statistically significant reduction in temperature through six hours in comparison to placebo (p<0.01), with an onset of action within 15 minutes after treatment.

OFIRMEV was well tolerated in clinical trials assessing safety in a range of patient and surgery types.

The safety and effectiveness of OFIRMEV for the treatment of pain and fever in pediatric patients older than two years is supported by evidence from adequate and well controlled studies in adults and additional safety and pharmacokinetic data for this age group. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than two years of age.

Future Commitments

As required under its existing license agreement for OFIRMEV, Cadence will make a milestone payment of $15 million as a result of the U.S. approval of the product.

In accordance with a Pediatric Resear
'/>"/>

SOURCE Cadence Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the 2008 NewsMakers In the Biotech Industry Conference
2. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the JMP Securities Third Annual Healthcare Focus Conference
3. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the BIOCOM Investor Conference
4. Cadence Pharmaceuticals to Host Conference Call and Webcast to Discuss Third Quarter 2008 Financial Results and Provide a Clinical Program Update on November 6, 2008
5. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the Roth Capital Partners 21st Annual OC Growth Stock Conference
6. Cadence Pharmaceuticals to Host Conference Call and Webcast to Discuss Fourth Quarter and Full Year 2008 Financial Results and Corporate Update on March 12, 2009
7. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at BioCentury Publications Inc. Future Leaders in the Biotech Industry Conference in New York on April 2, 2009
8. Cadence Pharmaceuticals Announces Presentations at Upcoming Scientific Conferences
9. Cadence Pharmaceuticals CEO Ted Schroeder to Present at Two Investment Conferences During the Month of May 2009
10. Cadence Pharmaceuticals Reports First Quarter 2009 Financial Results
11. Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... , July 11, 2014 , ... part) in, into or from any jurisdiction where to do ... such jurisdiction.  Shire plc ("Shire" or the "Company") ... article this afternoon.  Shire confirms it has held a meeting ... made by Shire without the prior agreement or approval of ...
(Date:7/11/2014)... July 11, 2014 EPFL and ... the appointment of John P. Donoghue . The ... Geneva . The new Wyss ... in Geneva , has named as ... John P. Donoghue , founder of Brown University,s ...
(Date:7/11/2014)... 11, 2014 Cayenne Medical, Inc., ... in the soft tissue reconstruction segment, announced the ... for surgeries involving the shoulder and extremities. The ... novel, inserter-controlled deployment method. The unique delivery eliminates ... anchor pull-out, or anchor displacement (also commonly know ...
(Date:7/10/2014)... UK (PRWEB) July 10, 2014 ... 21st Century Medicine Forum on ‘Commercialising Longevity Research’ ... and entrepreneurs to the London Bioscience Innovation Center ... Research Foundation and Aging Analytics Ltd. The meeting ... investment in translational research for age-related disease, as ...
Breaking Biology Technology:Shire plc - Statement re: Media Speculation 2John P. Donoghue is Taking the Lead at the Wyss Center and is Appointed Professor at EPFL and University of Geneva 2John P. Donoghue is Taking the Lead at the Wyss Center and is Appointed Professor at EPFL and University of Geneva 3Cayenne Medical Launches SureLock™ All-Suture Anchor System for Shoulder and Extremity Surgery 2Cayenne Medical Launches SureLock™ All-Suture Anchor System for Shoulder and Extremity Surgery 3DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 2DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 3DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 4DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 5DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 6
... Therapeutics, LLC, a biopharmaceutical company focused on the ... a $55 million Series C financing. The financing ... development and healthcare investment firm. The company ... Phase III clinical development program for its lead ...
... widely used drugs, is also one of the trickiest to ... of serious problems when given the standard starting dose. , ... based on genetic information, an international research team has created ... the blood-thinning drug for each patient. , Three University ...
... Corporation (Nasdaq: PMD ) today announced fourth ... December 31, 2008. The Company also announced a ... of record as of March 6, 2009 to be ... the Company,s 50th consecutive quarterly dividend.The Company,s revenue for ...
Cached Biology Technology:Sopherion Therapeutics Secures $55 Million in Series C Funding 2Genetic information personalizes warfarin prescribing 2Genetic information personalizes warfarin prescribing 3Psychemedics Corporation Announces 2008 Year End Results 2Psychemedics Corporation Announces 2008 Year End Results 3Psychemedics Corporation Announces 2008 Year End Results 4Psychemedics Corporation Announces 2008 Year End Results 5
(Date:7/10/2014)... BLUE BELL, Pa. , July 2, 2014  Unisys ... The Netherlands , Unisys Nederland N.V., today announced that ... (DJI) to deliver, implement and manage a new Basic Provision ... . Unisys won the contract with a ... for identity management software. The term of the contract is ...
(Date:7/10/2014)... -- Research and Markets ( http://www.researchandmarkets.com/research/h7h8lq/gesture ) has ... Recognition & Touch-Less Sensing (2D, 3D, Ultrasonic, IR, ... to their offering http://photos.prnewswire.com/prnh/20130307/600769 ... Sensing Market to Grow Exponentially. Touch-less sensing applications ... companies were unable to leverage this technology due ...
(Date:7/10/2014)... 2014  Acuity Market Intelligence today released forecasts from "The ... that the global market for National Electronic ID (eID) programs ... During this time, the number of National eID cards in ... Asia , with its vast population, will dominate ... issued, while Europe trails a distant ...
Breaking Biology News(10 mins):Unisys Delivers New Basic Provision Biometrics Solution to Dutch Custodial Institutions Service 2Unisys Delivers New Basic Provision Biometrics Solution to Dutch Custodial Institutions Service 3Global Gesture Recognition & Touch-Less Sensing (2D, 3D, Ultrasonic, IR, Capacitive) Market - Forecasts to 2020 2National Electronic ID Programs Generate $54 Billion Between 2013 and 2018 with 3.5 Billion National eID Card Holders Worldwide 2
... Michigan have found a new potential benefit of a ... proteins in the brain. The aggregation of ... disease and other neurodegenerative conditions., A paper published recently ... Sciences explained how U-M Life Sciences Institute faculty ...
... March 5, 2013 UT Southwestern Medical Center scientists report ... model of an incurable human cancer. "To my knowledge, this ... defined malignant human cancer has been generated in which the formation ... in which blocking the pathway cures the mouse of the tumor," ...
... technology could soon experience a significant upgrade that would ... the development of a new key material by a ... Department of Biomedical Engineering at Texas A&M University. ... signals that can be used to produce an image, ...
Cached Biology News:Green tea extract interferes with the formation of amyloid plaques in Alzheimer's disease 2UT Southwestern scientists make mouse model of human cancer, demonstrate cure 2UT Southwestern scientists make mouse model of human cancer, demonstrate cure 3Texas A&M research contributes to improved ultrasound imaging 2
D.R. Harper (1993) • Includes: essential information on taxonomy, culture and safe handling of viruses, immunology, monoclonal antibodies, antivirals and vaccines....
...
Performance, mycoplasma, virus, and endotoxin tested. Collected from calves 14 days old or less...
...
Biology Products: