Navigation Links
Orexigen and FDA Identify a Clear and Feasible Path to Approval for Contrave®
Date:9/20/2011

erim and final analyses, respectively. Both FDA and Orexigen estimate that such a study would require approximately 87 total events by the interim analysis to enable resubmission of the NDA for approval.  Orexigen estimates that the entire study would require less than 10,000 patients and less than two years from study start to the interim analysis. The Company plans to meet with the review division to finalize a protocol with the objective of initiating the CVOT in the first half of 2012, with potential approval in 2014.

Based on this new feedback from FDA outlining a clear and feasible path forward for Contrave, the Company's three near-term priorities for the program are to: (1) finalize the trial protocol with FDA; (2) re-engage with parties that expressed interest in partnering the ex-North American markets for Contrave; and (3) implement the CVOT as soon as it is able.

"In my experience, Contrave demonstrated great potential for the treatment of obesity in a broad range of patients," said Ken Fujioka, MD, director of the Nutrition and Metabolic Research Center and The Center for Weight Management at the Scripps Clinic, and investigator for the Contrave Obesity Research Program.  "On behalf of those working hard to address this significant unmet need, I am pleased to see that a pragmatic approach to bringing this therapy to market appears to be taking shape."

Orexigen management will host a conference call and webcast to discuss this update today at 4:30 p.m. Eastern time.  The live call may be accessed by phone by calling (866) 730-5763 (domestic) or (857) 350-1587 (international), participant code 66064656.  The webcast can be accessed live on the investor relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.

About Contrave

Contrave, an investigational combination therapy of naltrexone HCl and bupro
'/>"/>

SOURCE Orexigen Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Orexigen® Therapeutics Reports Second Quarter Ended June 30, 2011 Financial Results
2. Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA
3. Orexigen® Therapeutics Reports First Quarter Ended March 31, 2011 Financial Results
4. Orexigen® Therapeutics Reports Fourth Quarter and Year Ended December 31, 2010 Financial Results
5. Orexigen® Therapeutics Schedules March 10, 2011 Webcast Discussion of Financial Results for the Fourth Quarter and Year Ended December 31, 2010
6. Orexigen® Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer
7. Orexigen® Therapeutics Investigational Drug Contrave® Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity
8. Orexigen® Therapeutics Reports Third Quarter 2010 Financial Results
9. Orexigen® Therapeutics to Speak at Fifth Annual JMP Securities Healthcare Conference
10. Orexigen® Therapeutics to Speak at Rodman & Renshaw Annual Global Investment Conference
11. Orexigen® Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave® in North America
Post Your Comments:
*Name:
*Comment:
*Email:
(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)... Thoratec Corporation (NASDAQ: THOR ), ... to save, support and restore failing hearts, said today ... Global Healthcare Conference on Wednesday, September 10. ... Officer, will provide an update on the company, beginning ... Daylight Time).   A webcast of the ...
(Date:8/29/2014)... 2014 Research and Markets  has announced the ... 2014" report to their offering. The ... of the largest segments of pharmaceuticals industry. The numbers of ... available therapies were unable to meet the market requirements. There ... CNS disorder, especially over the past two decades. The market ...
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 3US CNS Disorders Drug Pipeline Insight 2014 2
... Tenn. , Jan. 20 Cumberland Pharmaceuticals Inc. ( ... ) Injection, an intravenous form of ibuprofen, to Haitian relief effort. ... for the treatment of pain and reduction of fever in ... continue to deteriorate, Caldolor is expected to help those suffering from ...
... , , LOS ANGELES , ... that it has joined forces with New Jersey -based ... create the nation,s first IVF insurance program. The Assisted Reproduction ... financial solutions for the ever-rising costs of In Vitro Fertilization ...
Cached Medicine Technology:Cumberland Pharmaceuticals Donates Caldolor(R) to Haitian Relief Effort 2Cumberland Pharmaceuticals Donates Caldolor(R) to Haitian Relief Effort 3New Life Agency, Inc. Joins Forces With The Diamond Institute and Walgreens Specialty Pharmacy to Introduce the Nation's First In Vitro Fertilization Insurance Program 2New Life Agency, Inc. Joins Forces With The Diamond Institute and Walgreens Specialty Pharmacy to Introduce the Nation's First In Vitro Fertilization Insurance Program 3
(Date:8/29/2014)... Highly regarded audiologist , Dr. Mary Ann Larkin has ... four reports are titled:, , Revealing the Truth ... , The Top 5 Things You Should Know Before ... in Children , Dr. Mary Anne Larkin choose to ... confusion and misinformation about each them. The reports are available ...
(Date:8/29/2014)... La Mirada, CA (PRWEB) August 29, 2014 ... multidisciplinary healthcare organizations, acquired a new medical center from LAXMed. ... LAX airport and less than 2 miles west of the ... Healthpointe center within Southern California. The new LAX center is ... CA 90045. , The new Healthpointe LAX ...
(Date:8/29/2014)... August 29, 2014 The family of ... a series of dialysis treatments has filed a GranuFlo ... was the result of Fresenius Medical Care’s GranuFlo and ... lawsuit, which was file d in Alameda County Superior ... of the products resulted in metabolic alkalosis, a ...
(Date:8/29/2014)... IL (PRWEB) August 29, 2014 ... “The Safety Chick” who profiled a handful of ... Earphones from Etymotic Research. This year, many schools ... and Etymotic, an innovator of hearing wellness solutions, ... Their ETY•Kids Safe-Listening Earphones, offered in yellow, pink ...
(Date:8/29/2014)... Steven Reinberg ... News) -- The vast majority of American babies are ... serious illnesses, federal health officials said Thursday. More ... that prevent measles, mumps, and rubella (MMR); polio; hepatitis ... for Disease Control and Prevention. "Nationally, vaccination among ...
Breaking Medicine News(10 mins):Health News:Charleston SC Audiologist, Dr. Mary Ann Larkin Authors Four New Special Reports on Important Hearing Healthcare Topics 2Health News:Charleston SC Audiologist, Dr. Mary Ann Larkin Authors Four New Special Reports on Important Hearing Healthcare Topics 3Health News:Healthpointe Obtains a New Medical Clinic in the LAX Area 2Health News:GranuFlo Lawsuit News: Family Alleges Woman’s Death Following Dialysis Was Caused by GranuFlo and NaturaLyte, Bernstein Liebhard LLP Reports 2Health News:GranuFlo Lawsuit News: Family Alleges Woman’s Death Following Dialysis Was Caused by GranuFlo and NaturaLyte, Bernstein Liebhard LLP Reports 3Health News:GranuFlo Lawsuit News: Family Alleges Woman’s Death Following Dialysis Was Caused by GranuFlo and NaturaLyte, Bernstein Liebhard LLP Reports 4Health News:The Today Show Features ETY•Kids® Safe-Listening Earphones by Etymotic 2Health News:Most U.S. Babies Get Their Vaccines: CDC 2Health News:Most U.S. Babies Get Their Vaccines: CDC 3
... and global IT giant Tata Consultancy Services (TCS) have ... a global drug development center in Mumbai. ... variety of services in clinical research, including clinical data ... ,"GSK has chosen to partner with TCS because of ...
... official figures.// ,Statistics for 2006 show ... which protects against measles, mumps and rubella, as against the national ... is an increase from the previous year, when the figure was ... 1988, but levels of uptake began to decline after 1998 when ...
... decided to crackdown on unethical doctors who accept gifts from ... entrance. ,This move follows the rocketing costs ... such tests. , According to the new law ... up to 5 years in jail, in terms of prosecution ...
... of persons infected with deadly viruses such as HIV and ... understand how. // , An independent inquiry is soon ... by almost 2000 hemophilia patients, via blood transfusions, in what ... of UK’s National Health Services. , The ...
... the “triple negative” type are destructive and lethal, and tend ... novel// study Published in the May 1, 2007 issue of ... occur commonly among women who are African American and Hispanic, ... socioeconomic status (SES). The study also showed that triple negative ...
... found that the most potent cholesterol-lowering drug is ... blood vessels that can lead to atherosclerosis. ... arteries compared to a placebo,” said John R.Crouse, ... at Wake Forest University School of Medicine. “The ...
Cached Medicine News:Health News:Scotland’s Parents Still a Little Wary of MMR Shot 2Health News:Inquiry into Past NHS Treatment Disaster 2Health News:'Triple Negative' Breast Cancers Seem to Affect the Young, Minority 2Health News:Cholesterol-lowering Drug Effective at Halting Early Atherosclerosis 2
Sprint Quattro Secure™ is a Steroid-Eluting, True Bipolar, Active Fixation ICD Lead....
TVL defibrillation leads have a patented coiled-coil design for faster, easier insertion and more precise intracardiac placement. Designed with an integrated bipolar design, the lead enables high-vol...
The TVL-ADX lead is a thin, high-performing defibrillation lead that offers a true bipolar configuration designed for smarter sensing and low defibrillation threshold for greater patient safety margi...
... SPL defibrillator lead features a ... the flexibility and maneuverability of ... the physician who prefers a ... the SPL lead also promotes ...
Medicine Products: