Navigation Links
-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-
Date:7/20/2009

SAN DIEGO, July 20 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX) today announced that all three remaining Phase 3 trials evaluating Contrave(R) (bupropion SR/naltrexone SR), its investigational drug for the treatment of obesity, met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first half of 2010.

Key top-line data from the COR Phase 3 program include the following:

  • 48.0% and 56.3% of patients on Contrave32(1) in COR-I (NB-301) and COR-II (NB-303) lost at least 5% of their body weight after 56 weeks, approximately three times the placebo categorical response rates of 16.4% and 17.1%, respectively (ITT, p<0.001).
  • Contrave patients in COR-I and COR-II on Contrave32 had mean weight loss of 6.1% and 6.4% after 56 weeks, compared to 1.3% and 1.2% on placebo, respectively (ITT, p<0.001).
  • In the COR-Diabetes (NB-304) trial, 44.5% of patients on Contrave32 lost greater than or equal to 5% of their body weight after 56 weeks, more than double the 18.9% of patients on placebo (p<0.001). Contrave patients also showed a 0.6% reduction in HbA1c from baseline, compared to a 0.1% reduction in placebo. This difference of 0.5% is clinically and statistically significant (ITT, p<0.001).
  • Key secondary endpoints met across the entire COR Phase 3 program included significant improvements in cardiovascular and metabolic risk factors such as waist circumf
    '/>"/>

SOURCE Orexigen Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine news :

1. Blacks Have Highest Obesity Rates in U.S.
2. Video: Sodexo Takes on Childhood Obesity in School Cafeterias
3. Obesity Contributes to Rapid Cartilage Loss
4. Obesity contributes to rapid cartilage loss
5. Childhood obesity link to parents
6. Study finds citrus-derived flavonoid prevents obesity
7. Is obesity an oral bacterial disease?
8. The Obesity Society Selects Executive Vice President
9. Obesity Rates Continue to Climb in U.S.
10. New Report Finds Obesity Epidemic Increases, Mississippi Weighs in as Heaviest State
11. Equine Obesity is Associated with Significant Health Issues, Including Insulin Resistance and Laminitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/30/2014)... According to the latest review on DailyGossip.org, this is ... skin health. It seems that the method is so popular ... 138,000 patients from all over the world. , The ... method will not only eliminate acne forever, but will also ... this program unique among other methods of curing candida is ...
(Date:8/30/2014)... Capital Region, NY (PRWEB) August 31, 2014 ... the largest and fastest growing union in New York ... bringing good, middle-class healthcare jobs and the best quality ... regions. , In recent years, thousands of healthcare ... for themselves and their families by becoming members of ...
(Date:8/30/2014)... UWDress.com, a distinguished wedding dress supplier, has gained ... of fashionable outfits. Recently, the company has unveiled its beautiful ... autumn special offer, all these brand new products are provided ... “We are excited to unveil the new and trendy bridesmaid ... products are available at low prices now. The purpose of ...
(Date:8/30/2014)... San Diego, CA (PRWEB) August 30, 2014 ... Rebecca Doherty upheld a decision that requires Takeda Pharmaceutical ... billion in punitive damages for claims that the drugmakers ... with the diabetes medication Actos. The case, Allen v. ... the U.S. District Court, Western District of Louisiana (Lafayette).* ...
(Date:8/30/2014)... United Theological Seminary is pleased to announce the launch ... Theological Studies (MTS). , This degree, which ... who wish to pursue further academic study of religion (Ph.D.) ... Church and community. Previously, students needed to be on campus ... from any location where there is an internet connection. ...
Breaking Medicine News(10 mins):Health News:Acne No More Review Reveals Unusual Tip to Eliminate Acne Permanently 2Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 2Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 3Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 4Health News:UWDress.com’s Beautiful Collection Of “Flowy Bridesmaid Dresses” Released 2Health News:The Law Office of Melinda J. Helbock A.P.C. Comments on Decision to Uphold $9 Billion Actos Award 2Health News:United Theological Seminary Announces First Fully Online Degree 2
... GUANGZHOU, China, July 17 /Xinhua-PRNewswire/ -- China ... or "the Company"),a leading distributor and developer ... (TCMs), nutritional and dietary supplements,medical devices, and ... China,(PRC), announced today that it obtained a ...
... 17 Fresh Harvest Products,Inc. (OTC Bulletin Board: ... its long standing commitment to providing consumers with ... new initiative to,build natural and organic brands and ... Harvest brands,through our network., "We believe that ...
... /Xinhua-PRNewswire-FirstCall/ -- Mindray,Medical International Limited (NYSE: MR ... devices worldwide has announced today that it will,highlight ... well as,unveil three new units and reagents at ... conference. The conference will be attended,by Mr. Jie ...
... Calif., July 17 Cardica, Inc.,(Nasdaq: CRDC ... to the,position of vice president, operations. Mr. Bauer ... operations and manufacturing experience to,Cardica from large healthcare ... operations experience and his continuous drive to,improve quality ...
... 2, 2009 -, LAVAL, QC, July 17 /PRNewswire-FirstCall/ ... the response that it submitted to the,U.S. Food and ... analysis of existing data as suggested by the Agency, ... action date assigned by the,FDA under the Prescription Drug ...
... Ceremonies for the 23rd Annual Great Sports,Legends Dinner to Benefit The Buoniconti ... ... NEW YORK, July 17 Sports luminaries and philanthropy,icons will be recognized ... September 22, at New York,s Waldorf=Astoria,Hotel. This year, Bob Costas has been ...
Cached Medicine News:Health News:China Medicine Corporation Obtains Australian Patent for rADTZ 2Health News:China Medicine Corporation Obtains Australian Patent for rADTZ 3Health News:Fresh Harvest Products, Inc. Announces New Brand Initiative 2Health News:Mindray to Unveil Three New Products and Reagents at AACC Annual Meeting 2Health News:Mindray to Unveil Three New Products and Reagents at AACC Annual Meeting 3Health News:Cardica Names Frederick Bauer Vice President of Operations 2Health News:Cardica Names Frederick Bauer Vice President of Operations 3Health News:FDA accepts Labopharm's response for once-daily tramadol as complete Class 2 response 2Health News:Sports Luminaries Andre Agassi, Jerry Rice, Scottie Pippen, Helio Castrovenes, Richard 'Goose' Gossage Among Those Named 2008 'Great Sports Legends' 2Health News:Sports Luminaries Andre Agassi, Jerry Rice, Scottie Pippen, Helio Castrovenes, Richard 'Goose' Gossage Among Those Named 2008 'Great Sports Legends' 3
(Date:8/29/2014)... Pomerantz LLP has filed a class action ... EDAP ) and certain of its officers.  ... Southern District of New York , ... class consisting of all persons or entities who purchased ... 2014, inclusive (the "Class Period"). This class action seeks to ...
(Date:8/29/2014)...  BC Technical, the nation,s leading non-OEM provider of ... leader in sales, service and installation of GE MRI ... to continue to expand their resources and inventory while ... "We are committed to driving higher ... president and CEO of BC Technical. "We set out ...
(Date:8/29/2014)... Does your doctor know what you,re smoking?  Chances are, probably ... the over 112,000 currently registered patients under Colorado,s ... roughly 20,300+ active physicians listed with the Colorado Dept of ... though a poll in February 2014 showed 51% of ... "With marijuana legalization underway, every doctor needs ...
Breaking Medicine Technology:SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3BC Technical Acquires Polaris Medical Imaging 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 3Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 4
... 23, 2011 Dr. Michael Hayden, a Xenon founder ... Wightman Award for leadership in medical science in Canada. ... for Dr. Hayden, having previously been awarded the Order ... Institutes of Health Research,s Health Researcher of the Year ...
... 22, 2011 Boston Scientific Corporation (NYSE: BSX ... on April 4, 2011 at the 60th Annual Scientific Session ... The Company will provide an update on its Cardiology, Rhythm ... heart technologies.  The event is scheduled to begin at 6 ...
Cached Medicine Technology:Xenon Chief Scientific Officer, Dr. Michael Hayden Receives Prestigious Award for Leadership in Medicine 2
... 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 ...
... 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 ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... 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 ...
Medicine Products: