Navigation Links
Orexigen Therapeutics Reports Financial Results for the Third Quarter Ended September 30, 2012
Date:11/7/2012

partnership for the rest-of-world rights to Contrave and Empatic™. The additional capital we raised last month better positions us to execute on our corporate goals."

Product candidate update:
Contrave (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR) for the treatment of obesity: Orexigen has enrolled more than 8,000 patients in the Light Study. The primary objective of the double blind, randomized, placebo controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA (United States Food and Drug Administration), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. Orexigen now expects to randomize approximately 9,000 patients into the study. An interim analysis and New Drug Application resubmission is planned once at least 87 major adverse cardiovascular events (MACE) have occurred, which is anticipated in the second or third quarter of 2013.

In late October, Orexigen announced that it had received a response to a formal dispute resolution request (FDRR) from the United States FDA's Center for Drug Evaluation and Research (CDER). The response indicated that CDER highly supports further discussions regarding a faster path to resubmission of the Contrave New Drug Application (NDA). Orexigen plans to explore with the FDA the possibility of resubmitting the Contrave NDA in advance of the interim data from the Light Study. Under this scenario data from the planned interim analysis would be provided during the anticipated review period. Although procedural details need to be addressed, the Company is optimistic that these discussions could result in a faster path to resubmission of the Contrave NDA.

Empatic, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: The Company is communicating with the FDA regarding Empatic Phase III clinical development plans and to reconfirm with the Agency that reas
'/>"/>

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

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Unigenes Potent, Anorexigenic Peptide, UGP281, Demonstrates Dramatic Dose Dependent Reductions in Food Intake with Subsequent Significant Body Weight Reduction in Preclinical Studies
2. Orexigen Therapeutics to Present at the Jefferies 2012 Global Healthcare Conference
3. Orexigen Therapeutics to Present at the JMP Securities Healthcare Conference
4. Orexigen Therapeutics Announces the Light Study is Enrolling Faster than Originally Projected
5. Orexigen Therapeutics Schedules August 7, 2012 Webcast Discussion of Financial Results for the Second Quarter Ended June 30, 2012
6. Orexigen Therapeutics Reports Financial Results for the Second Quarter Ended June 30, 2012
7. Orexigen Therapeutics Announces Presentations at Upcoming Investor Conferences
8. Orexigen Therapeutics announces continued rapid enrollment into the Light Study; enrollment now expected to close by year end 2012
9. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
10. Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing in Chelsea Therapeutics International, Ltd. to Contact the Firm
11. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... 2014 Nektar Therapeutics (NASDAQ: ... positive results from its Phase 3 pivotal clinical ... recombinant factor VIII (rFVIII) treatment for hemophilia A ... its primary endpoint in reducing annualized bleed rates ... on-demand arm. Top-line results from the ...
(Date:8/21/2014)... Texas , Aug. 21, 2014  eRelevance ... services company, announced today that it has completed ... (EMR) solution for Plastic Surgery and Dermatology practices. ... even more value to healthcare practices using Nextech," ... of eRelevance Corporation. "Using information from the EMR ...
(Date:8/21/2014)... , Aug. 21, 2014 The spinal column is ... human body. Signals carried to and from the brain through ... and nervous system. Injury or ailment here can be life ... a loss of control over their body. Though back injury ... person,s life, there are more options available to make things ...
Breaking Medicine Technology:Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 2Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 3Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 4Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients 5eRelevance Corporation Integrates with Nextech Electronic Medical Records 2Don't Live in Pain: Four Life Improving Benefits of Back Surgery 2
... BIOSAFE, Inc. , a company that manufactures and ... are launching in specific markets outside the United States ... Crosstex, new BIOSAFE-treated Ultra Sensitive facemasks begin to ... upon contact, and have further proven to be effective ...
... Shire plc (LSE: SHP,NASDAQ: SHPGY ), the ... pending litigation with Sandoz, Inc. ("Sandoz") in,connection with Sandoz,s ... generic versions of Shire,s ADDERALL XR(R) (mixed,amphetamine salts) for ... The settlement also provides Sandoz with a ...
Cached Medicine Technology:BIOSAFE Launching In a New Specially-Treated Facemask Effective Against H1N1 Influenza 2BIOSAFE Launching In a New Specially-Treated Facemask Effective Against H1N1 Influenza 3BIOSAFE Launching In a New Specially-Treated Facemask Effective Against H1N1 Influenza 4Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R) 2Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R) 3
(Date:8/21/2014)... The W. Montague Cobb/ NMA Health ... voice in the elimination of health disparities, honored ... 112th National Medical Association’s (NMA) Annual Convention and ... Ruffin, Ph.D, former Director of the National Institute ... career and innovations have had a significant impact ...
(Date:8/21/2014)... York, New York (PRWEB) August 21, 2014 ... filed against C.R. Bard, Inc. continue to move ... U.S. District Court, Southern District of West Virginia, ... Order issued on August 14th, the Court has ... evidence that requires special handling, division, storage and ...
(Date:8/21/2014)... A new study published this week in ... associated with speech problems from 2001-02 to 2010-11 among ... in disability associated with hearing problems. The data underscore ... children who are experiencing communication disorders, according to the ... a broader level, the new study, Changing Trends ...
(Date:8/21/2014)... Seattle, WA chiropractors Dr. Lincoln Kamell ... and Massage Center have recently welcomed two new ... Lang, LMP and Mike Larios, LMP have specialized training ... and have developed their expertise working in a variety ... in a clinical environment where massage is used on ...
(Date:8/21/2014)... To sexually objectify a woman is to focus on ... sexual pleasure rather than viewing her as a complete ... long been considered a problem in the media, how ... in Psychology of Women Quarterly , a SAGE ... body is related to higher incidents of sexual pressure ...
Breaking Medicine News(10 mins):Health News:W. Montague Cobb/NMA Health Institute Honors Three Outstanding Leaders in Health Disparities 2Health News:Transvaginal Mesh Lawsuits Move Forward in Federal C.R. Bard Litigation with Issuance of New Pretrial Order, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward in Federal C.R. Bard Litigation with Issuance of New Pretrial Order, Bernstein Liebhard LLP Reports 3Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 2Health News:New Pediatrics Study Reveals Dramatic Increase in Speech Problems in Children Over Past Decade 3Health News:Seattle’s Eastlake Chiropractic and Massage Center Is Pleased to Introduce Rina Lang and Mike Larios as New Members of Its Massage Therapy Team 2Health News:Seattle’s Eastlake Chiropractic and Massage Center Is Pleased to Introduce Rina Lang and Mike Larios as New Members of Its Massage Therapy Team 3Health News:Objectification in romantic relationships related to sexual pressure and coercion 2
... are main barriers to adoption , , , WEDNESDAY, March 25 ... the United States have comprehensive electronic health record systems currently ... to adopting such systems are costs, which can run as ... of doctors to change their ways, experts say. , "President ...
... Group Led by Former Rep. Gephardt Underscores Importance ... Cures for Life-Threatening Diseases , WASHINGTON, March 25 ... President Obama on his support for improving our ... through continued scientific and technological advancements. (Logo: ...
... The US Department of Homeland Security, Federal Emergency ... Bureau Veritas North America for a period of six ... units (THUs) in Louisiana and Mississippi. FEMA exercised its ... continue to provide formaldehyde sampling services for temporary housing ...
... treatments prevents Honolulu residents from ... March 25 Taking Control of Your Diabetes (TCOYD) ... national research firm Yankelovich that found that although Honolulu ... educated about diabetes management than the majority of their ...
... new era of treatment to save tiniest babiesCLEVELAND, March 25 , ... provides individual rooms with sleep accommodations so parents can stay with their ... Innovative care design that creates a healing environment with natural materials ... building materials incorporated throughout NICU. , ...
... The Christopher & Dana Reeve Foundation, the national, ... spinal cord injuries and improving the lives of people ... Representatives for passing the Christopher and Dana Reeve Paralysis ... Public Land Management Act. The legislation was named for ...
Cached Medicine News:Health News:Few Hospitals Embracing Electronic Health Record Systems 2Health News:Few Hospitals Embracing Electronic Health Record Systems 3Health News:Few Hospitals Embracing Electronic Health Record Systems 4Health News:Council for American Medical Innovation Applauds President Obama for Calling for 'Serious Investments in Science and Technology' 2Health News:FEMA Extends Formaldehyde Testing Contract with Bureau Veritas 2Health News:Survey Reveals Honolulu Residents Perceive Financial Challenges as Main Barrier in Properly Managing Their Type 2 Diabetes 2Health News:Survey Reveals Honolulu Residents Perceive Financial Challenges as Main Barrier in Properly Managing Their Type 2 Diabetes 3Health News:Survey Reveals Honolulu Residents Perceive Financial Challenges as Main Barrier in Properly Managing Their Type 2 Diabetes 4Health News:Rainbow Babies & Children's Hospital Opens Most Technologically Advanced NICU in World 2Health News:Rainbow Babies & Children's Hospital Opens Most Technologically Advanced NICU in World 3Health News:Rainbow Babies & Children's Hospital Opens Most Technologically Advanced NICU in World 4Health News:Christopher & Dana Reeve Foundation Applauds Historic Passage of the Christopher and Dana Reeve Paralysis Act 2Health News:Christopher & Dana Reeve Foundation Applauds Historic Passage of the Christopher and Dana Reeve Paralysis Act 3
... Bird and Cronin, ... manufacturer of Patient Footwear, ... Patient Care Products. Our ... highest quality and available ...
Foam Cervical Collar is medium-firm density. Breathable. Deeply anatomically contoured. Natural color, 100% cotton stockinette-covered for comfort. 2" hook and loop closures are another mark of quali...
Exo-Deluxe Overhead Traction for hospital or home care. Twice the clearance of other units between the patient and supporting wall. 2" nylon pulleys with polypropylene cord, head halter, spreader bar...
Wonderflex™ is a lined soft durometer silicone gel sheet. It is ideal for cushioning orthotic/prosthetic devices and offers protection from shock and sheer forces. Wonderflex can also be lamina...
Medicine Products: