Navigation Links
Orexigen Resubmits Contrave New Drug Application
Date:12/11/2013

SAN DIEGO, Dec. 11, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company has resubmitted the Contrave® New Drug Application to the United States (U.S.) Food and Drug Administration (FDA). Investigational drug Contrave (naltrexone sustained release (SR) / bupropion SR) is being developed for weight loss and maintenance of weight loss.

The resubmission follows the November 25, 2013 announcement of the successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial (CVOT), which is being conducted under a Special Protocol Assessment with the FDA. In January 2011, Orexigen received a Complete Response Letter (CRL) from the FDA detailing a single approval deficiency—the need to conduct a clinical trial of sufficient size and duration to exclude excess risk of major adverse cardiovascular events. In less than three years, Orexigen negotiated with FDA a feasible CVOT design, enrolled the CVOT, and generated safety data responsive to the CRL.

"Resubmitting the Contrave NDA is an exciting moment for Orexigen," said Michael Narachi, CEO of Orexigen. "I am proud of our team and admire their determination to bring Contrave forward to help patients with obesity."

Narachi continued: "This resubmission sets in motion the first of four potential key catalysts in 2014. With the successful Light Study interim analysis, we are confident in the prospect for approvals next year in the United States and in Europe. If Contrave is approved, we look forward to a well-executed U.S. launch by Takeda. Additionally, we anticipate making progress next year in our discussions with potential partners for Contrave for territories outside North America.
'/>"/>

SOURCE Orexigen Therapeutics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Orexigen Therapeutics, Inc. Announces the Closing of its Offering of $115 Million of Convertible Senior Notes
2. Orexigen Therapeutics to Present at the 25th Annual Piper Jaffray Healthcare Conference
3. Orexigen Announces Successful Interim Analysis of Contrave Light Study
4. Orexigen Therapeutics to Host Contrave Light Study Interim Analysis Conference Call and Webcast
5. Orexigen Therapeutics Reports Business and Financial Results for the Third Quarter Ended September 30, 2013
6. Orexigen and Takeda Announce Multiple Contrave Data Presentations at the ObesityWeek Meeting in Atlanta
7. Orexigen Therapeutics Enters Into Agreement with Sanofi to Manufacture Contrave for Territories Outside North America
8. A Balanced Risk-Benefit Profile Will Propel Orexigen/Takedas Contrave to Become the Most Widely Used Emerging Therapy for the Treatment of Obese and Overweight Patients
9. Orexigen Therapeutics Announces Date of Third Quarter 2013 Financial Results Conference Call and Upcoming Presentation at Credit Suisse Healthcare Conference
10. Orexigen Therapeutics to Present at the Bank of America Merrill Lynch Global Healthcare Conference
11. Orexigen Therapeutics Announces European Filing Strategy and Reports Business and Financial Results for the Second Quarter Ended June 30, 2013
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... , Jan. 23, 2015  A new analysis of ... D 2015 enrollment data shows that 81 percent of ... access and extra discounts at certain pharmacies. The findings ... "Preferred pharmacy plans are now the foundation of Medicare ...
(Date:1/23/2015)... 23, 2015  MedScope ( www.medscope.org ), the leading provider ... 2015 Connected World magazine Connected World Award ... that can be used anywhere, anytime. The nomination was ... In nominating MedScope, Landon Garner , Director ...
(Date:1/23/2015)... DUBLIN , Jan. 23, 2015  Immune Therapeutics, Inc. ... Biotechnology, Inc. for the compounding, packaging and distributing of its ... the United States . ... of compounding naltrexone tablets in various strengths for individual patients ...
Breaking Medicine Technology:New Analysis: 81 Percent of Medicare Part D Seniors Choose "Preferred Pharmacy" Plans in 2015 2MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 3Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 4
... MARY, Fla., Sept. 29, 2011 PediaVision today ... is the first in the State of California ... PediaVision called "Spot."  The University,s Department of Ophthalmology ... Riverside County, thanks to the support of ...
... 29, 2011 Atrium Medical Corporation today announced ... Journal of Vascular Surgery.  COBEST ( Covered Versus ... landmark, prospective, multi center, randomized, controlled clinical trial ... covered stent technology is superior to traditional bare ...
Cached Medicine Technology:Loma Linda University Expands Vision Screening Program With Revolutionary New Screening Device, Spot 2Loma Linda University Expands Vision Screening Program With Revolutionary New Screening Device, Spot 3Loma Linda University Expands Vision Screening Program With Revolutionary New Screening Device, Spot 4Atrium Announces the Publication of the COBEST Trial by the Journal of Vascular Surgery 2Atrium Announces the Publication of the COBEST Trial by the Journal of Vascular Surgery 3
(Date:1/22/2015)... 2015 Padre Murphy's and Owner Tom Boyle ... Pro Player Health Alliance (PPHA). The PPHA's passion for ... everyone, including NFL greats, treated for obstructive sleep apnea (OSA) ... supporting the cause in the valley. The most recent plans ...
(Date:1/22/2015)... January 23, 2015 AngelWeddingDress, the premier ... 2015 maternity wedding dresses. View website of ... looking for maternity wedding dresses online for a bridal ... with high quality for them. Its maternity wedding dresses ...
(Date:1/22/2015)... Autocarinsurancebest.com has released a new blog post ... insurance policy . , Auto insurance quotes help many ... no longer necessary to call an agent or visit an ... on a single website: http://autocarinsurancebest.com/ . , Every business ...
(Date:1/22/2015)... Yesterday, Senator Holly Mitchell (D-Los ... Olsen (R-Modesto) were honored by the California Healthcare ... biomedical science, medical device and pharmaceutical innovation in ... “2014 Life Sciences Champion” award from CHI President ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 EBSCO Information ... (AMA) are expanding their relationship in an effort to further ... the world. While EBSCO has long made AMA journals available ... sales agent for The JAMA Network. , Long ...
Breaking Medicine News(10 mins):Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 2Health News:Padre Murphy's Holds NFL Retired Players Association Party Star Studded Event With Bud Light and Pro Player Health Alliance Sponsoring 3Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4
... ... leading providers of accounts receivable management services, has moved its National Account Service Center ... ... 2010 -- TekCollect, one of the nation’s leading providers of accounts receivable management ...
... Calif. , Jan. 15 Nearly 7,500 registered nurses have ... to be the largest outpouring of RN volunteers in U.S. history, reports ... clock to find locations for the nurses to deploy on the ground ... the NNU program as well. , View the attached volunteer ...
... SAN FRANCISCO , Jan. 15 A Good Idea ... in San Francisco , plans to give $100,000 to ... the Chase Community Giving contest sponsored by JPMorgan Chase & Co. , ... within the Bay Area, we feel that it is of the utmost importance ...
... To meet ... as part of the coordinated United Nations Flash Appeal. , ... United Nations, NY (Vocus) January 15, 2010 -- Estimates that ... by Haiti’s earthquake have led to an urgent appeal to meet their emergency maternal health ...
... , Jan. 15 /PRNewswire-FirstCall/ - NUCRYST Pharmaceuticals Corp. ... distributing to shareholders an additional supplement (the "Supplement") to the ... previously delivered to shareholders in connection with the Special Meeting ... . The special meeting was originally held to consider a ...
... provides data on sources of public and private funds , ... the level of funding for biomedical research in the United ... study shows. , The same review also found that the ... An analysis of data showed that funding of biomedical research ...
Cached Medicine News:Health News:TekCollect Opens New National Account Service Center and Corporate Headquarters 2Health News:Nearly 7,500 RNs Ready to Deploy to Haiti 2Health News:San Francisco Charity A GOOD IDEA to Give $100,000 to Haiti Victims Upon Winning Nationwide Charity Program 2Health News:Appeal Launched for Emergency Assistance to Thousands of Pregnant Women at High Risk in Haiti 2Health News:NUCRYST Announces Distribution of Supplemental Information In Connection with Special Meeting of Shareholders 2Health News:NUCRYST Announces Distribution of Supplemental Information In Connection with Special Meeting of Shareholders 3Health News:NUCRYST Announces Distribution of Supplemental Information In Connection with Special Meeting of Shareholders 4Health News:Money for Biomedical Research Cut in Recent Years 2
... 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 ...
... 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 ...
... 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 ...
... 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: