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:7/30/2015)... -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today ... the second quarter ending June 30, 2015. ... organization.  We are excited to be near the completion ... conducted with topline results expected in the fourth quarter," ... Therapeutics, Inc. "Translarna is now commercially available in 12 ...
(Date:7/30/2015)... WOODCLIFF LAKE, N.J. , July 30, 2015 /PRNewswire/ ... submitted simultaneously in the United States ... (to the FDA, EMA and MHLW, respectively) for eribulin, ... sarcoma (STS) who have received prior chemotherapy for advanced ... are based on data from a pivotal global Phase ...
(Date:7/30/2015)... FAIRFIELD, N.J. , July 30, 2015 /PRNewswire/ ... Ferrer, completed the second Phase III clinical study ... development for impetigo.  Medimetriks owns the exclusive U.S. ... The global trial, conducted at 44 centers with ... and pediatric patients aged 2 months and older ...
Breaking Medicine Technology:PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 2PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 3PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 4PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 5PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 6PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 7PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 8PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 9PTC Therapeutics Reports Second Quarter 2015 Financial Results and Provides Corporate Update 10Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 2Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 3Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 4Eisai Submits Simultaneous Regulatory Applications for Eribulin in Soft Tissue Sarcoma in the United States, European Union and Japan 5Medimetriks Pharmaceuticals, Inc. Announces Completion of the Second Successful Pivotal Phase III Study for Ozenoxacin 2Medimetriks Pharmaceuticals, Inc. Announces Completion of the Second Successful Pivotal Phase III Study for Ozenoxacin 3
... Calif., Feb. 25, 2011 Accuray Incorporated ... the field of radiosurgery, announced today that its Senior Vice ... was named "Best General Counsel, Small Public Company" by the ... San Francisco Business Times as part of their ,Best ...
... Landauer, Inc. (NYSE: LDR ) announced today that ... $0.55 per share for the second quarter of fiscal 2011.  The ... record on March 11, 2011. About Landauer ... analytical services to determine occupational and environmental radiation exposure and is ...
Cached Medicine Technology:Accuray's General Counsel Wins Best Bay Area Corporate Counsel Award 2Accuray's General Counsel Wins Best Bay Area Corporate Counsel Award 3Accuray's General Counsel Wins Best Bay Area Corporate Counsel Award 4
(Date:7/30/2015)... ... July 30, 2015 , ... The ... BioPharma, Inc. are pleased to announce that data standards for clinical research in ... on the CDISC website . These three Therapeutic Area (TA) standards were ...
(Date:7/30/2015)... ... July 30, 2015 , ... In an effort to provide ... Aggarwal is making a change in his practice. , The decision will also allow ... 2015, Dr. Aggarwal will be transferring his in-patient admissions to the hospitalists at East ...
(Date:7/30/2015)... ... July 30, 2015 , ... Women's dating ... Lines ." It's for women interested in improving their love lives using specific ... which officially launched to the public early this morning, has drawn praise from ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... In a ... clients at Serenity Palms Drug Addiction Treatment Center have created an addiction graveyard. Sharing ... one of its most beloved residents, Rocky Hudson . Hudson (1945-2015) fell in ...
(Date:7/30/2015)... ... July 30, 2015 , ... ... is the recipient of three awards in the Service Industry Advertising Awards 12th ... for Choptank Transport, KRM Development Corporation and University of Maryland Shore Regional Health. ...
Breaking Medicine News(10 mins):Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 2Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 3Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 4Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 5Health News:River Valley Physician Dr. Aggarwal is Making Changes to his Practice 2Health News:Lovetraction Lines - Review Examining Simone Myers' New Online Course Released 2Health News:Serenity Palms Honors Rocky Hudson, an Advocate of AA and a Beloved Resident of Palm Springs 2Health News:Serenity Palms Honors Rocky Hudson, an Advocate of AA and a Beloved Resident of Palm Springs 3Health News:Mullin/Ashley Associates Takes Home Wins for Three Clients in the Service Industry Advertising Awards Annual Competition 2Health News:Mullin/Ashley Associates Takes Home Wins for Three Clients in the Service Industry Advertising Awards Annual Competition 3
... the all-natural weight management program, opened in Ottawa with the ... began their weight-loss journey on the Smart for Life(TM) program ... for 6 family members. As friends and relatives joined the ... exciting business opportunity. , "Smart for Life(TM) is ...
... and services company focused on global eClinical solutions for the clinical ... studies from European Sponsor clients. These new studies will seek to ... as the Indian subcontinent. , "We ... to be a direct result of our continued hard work in ...
... ... and CEO of Abraxis Health, will receive the Adaptive Business Leaders Organization,s 2009 ... Awards Event on October 28, in Newport Beach. , ... Santa Ana, CA (PRWEB) October ...
... ... launch of their "Tats for Tatas" fundraising campaign that will take place ... the company,s concerted efforts to raise awareness and funds for Breast Cancer ... the company will be donating 10% of all proceeds from sales throughout ...
... Pa., Oct. 15 Herley Industries, Inc. (Nasdaq: HRLY ... Fiscal Year ended August 2, 2009. , Fourth Quarter ... quarter of fiscal 2009 were $43.0 million compared to $37.9 ... fourth quarter of fiscal 2009, the Company recorded several significant ...
... Minnesota Nurses Point to Benefits for Patients, Nurse Staffing and ... A new Senate bill introduced today by Sen. Al ... of RNs in hospitals and other health care facilities, but ... transported and moved in the safest way possible, all while ...
Cached Medicine News:Health News:Smart for Life(TM) Center Opens in Ottawa 2Health News:DATATRAK Announces the Award of New Studies from European Pharmaceutical Clients 2Health News:DATATRAK Announces the Award of New Studies from European Pharmaceutical Clients 3Health News:Patrick Soon-Shiong, World Renowned Healthcare Visionary & Philanthropist, to Receive ABL's Leadership Award & Make Keynote Presentation, October 28, in Newport Beach 2Health News:Patrick Soon-Shiong, World Renowned Healthcare Visionary & Philanthropist, to Receive ABL's Leadership Award & Make Keynote Presentation, October 28, in Newport Beach 3Health News:Patrick Soon-Shiong, World Renowned Healthcare Visionary & Philanthropist, to Receive ABL's Leadership Award & Make Keynote Presentation, October 28, in Newport Beach 4Health News:Atomic Tattoos Announces "Tats for Tatas" October Fundraising Event to Benefit Local Breast Cancer Research 2Health News:Herley Reports Fourth Quarter and Year-End Results 2Health News:Herley Reports Fourth Quarter and Year-End Results 3Health News:Herley Reports Fourth Quarter and Year-End Results 4Health News:Herley Reports Fourth Quarter and Year-End Results 5Health News:Herley Reports Fourth Quarter and Year-End Results 6Health News:Herley Reports Fourth Quarter and Year-End Results 7Health News:Herley Reports Fourth Quarter and Year-End Results 8Health News:Herley Reports Fourth Quarter and Year-End Results 9Health News:Herley Reports Fourth Quarter and Year-End Results 10Health News:Herley Reports Fourth Quarter and Year-End Results 11Health News:Herley Reports Fourth Quarter and Year-End Results 12Health News:Nation's RNs Hail Sen. Franken's Support for Safe Patient Handling Measure 2
... opticians in a store environment. Optizone ... retail store industry by opticians. Optizone ... for Optizone 2000. It is written ... User friendly screen interfaces make learning ...
This product offers patient, product and practice cash management to ease the strain of practice administration....
... MaximEyes by First Insight is the ... records solution for eye care professionals. ... with Eyefinitys online servicesrequest VSP authorizations, ... MaximEyes offers EMR, scheduling, billing, demographics, ...
... software for eyecare professionals- Winx ... multi-office practice management system, using ... Winx Pro is a complete ... in effectively managing the administrative, ...
Medicine Products: