Navigation Links
VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
Date:12/29/2009

MOUNTAIN VIEW, Calif., Dec. 29 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two pivotal, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors.

"This NDA filing is a major milestone for VIVUS and the Qnexa program. The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities," stated Leland F. Wilson, chief executive officer for VIVUS. "The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity
2. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
3. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
4. VIVUS Announces Promotion of Peter Tam to President
5. VIVUS to Present at Lazard Capital Markets Healthcare Conference
6. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results
7. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
8. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
9. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
10. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
11. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... CITY, Calif., Aug. 3, 2015 AcelRx Pharmaceuticals, ... focused on the development and commercialization of innovative therapies ... business update and reported financial results for the three ... Business highlights include: , On July 23, 2015, ... adopted a positive opinion for Zalviso™ for the management ...
(Date:8/3/2015)... August 3, 2015 ReportsnReports.com ... research with 2020 forecasts as well as Global ... medical devices intelligence collection of its library. ... with 2020 forecasts spread across 164 pages, talking ... tables and figures is now available at ...
(Date:8/3/2015)... 3, 2015  Depomed, Inc. (NASDAQ: DEPO ) ... plc,s (NASDAQ: HZNP ) ("Horizon") announcement that it ... Board") set a record date to determine the shareholders ... The Depomed Board will review the request when it ... and contains the information required under Depomed,s bylaws, the ...
Breaking Medicine Technology:AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 2AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 3AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 4AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 5AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 6AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 7AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 8AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 9AcelRx Pharmaceuticals Provides Business Update and Reports Second Quarter and Six Months 2015 Financial Results 10Medical Simulation Market to see 14% CAGR to 2019 2Medical Simulation Market to see 14% CAGR to 2019 3Medical Simulation Market to see 14% CAGR to 2019 4Medical Simulation Market to see 14% CAGR to 2019 5Medical Simulation Market to see 14% CAGR to 2019 6Depomed Comments on Horizon Pharma Announcement 2Depomed Comments on Horizon Pharma Announcement 3Depomed Comments on Horizon Pharma Announcement 4Depomed Comments on Horizon Pharma Announcement 5Depomed Comments on Horizon Pharma Announcement 6
... Sigma-Aldrich Corporation (Nasdaq: SIAL ) will be presenting ... 31st Annual Cowen and Company Healthcare Conference on Tuesday, March ... presenting at 10:15 AM (EST). Barclays Capital 2011 Global ... Hotel, Miami, FL, presenting at 10:15 AM (EDT). ...
... SPRING, Md., March 4, 2011 New data suggest ... increase the risk for the birth defects cleft lip ... use the medication during pregnancy, the U.S. Food and ... ) Before prescribing topiramate, approved to treat ...
Cached Medicine Technology:FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate 2FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate 3
(Date:8/4/2015)... ... August 04, 2015 , ... The goal of looking ... the desire for invasive surgery to achieve this ideal is not. But minimally invasive ... crave without the high cost or lengthy recovery time, according to Valerie Goldburt, ...
(Date:8/4/2015)... ... August 04, 2015 , ... Nathan’s Famous was recently ... small, medium, and large businesses making an impact in their industry. Andrew Tropeano, the ... how the famous hot dog maker now offers a 50% Reduced Fat All-Beef ...
(Date:8/4/2015)... ... August 04, 2015 , ... IN AMERICA and the program's ... depression. Depression affects millions of Americans every single year. To help people obtain ... viewers with the latest segment produced with the assistance of several top medical ...
(Date:8/4/2015)... KS (PRWEB) , ... August 04, 2015 , ... ... today their partnership to make the Isabel Symptom Checker available to all users ... consumers a mechanism to check their symptoms in an easy, intuitive method, provides ...
(Date:8/3/2015)... ... 04, 2015 , ... Keeping strong to their ongoing commitment ... today announced extra savings on Florida Physical Therapy continuing education packages. ... on Physical Therapy Flex packages by entering the promo code "FL229" ...
Breaking Medicine News(10 mins):Health News:Considering fillers, tighteners or laser resurfacing? 2Health News:Considering fillers, tighteners or laser resurfacing? 3Health News:Considering fillers, tighteners or laser resurfacing? 4Health News:Celebrate Summer with Nathan’s Famous Original Selfie Sweepstakes 2Health News:Celebrate Summer with Nathan’s Famous Original Selfie Sweepstakes 3Health News:Isabel Healthcare Partners with the Kansas Health Information Network, Inc. to Deploy Isabel Symptom Checker within the MyKSHealth eRecord Personal Health Record 2Health News:Isabel Healthcare Partners with the Kansas Health Information Network, Inc. to Deploy Isabel Symptom Checker within the MyKSHealth eRecord Personal Health Record 3Health News:Elite Online CE Provider Offers Discounted Flexible Packages to Meet Florida Physical Therapy Continuing Education Requirements 2
... Iron Mountain to Host Free Webcast on Making a Smooth ... Iron Mountain Incorporated (NYSE: IRM ), the ... Exempla Healthcare, will share tips during an upcoming Webcast for ... (EMR). , , In this free, hour-long Webcast, attendees ...
... Va., June 4 GTSI Corp.(R) (Nasdaq: ... services provider to government and healthcare organizations, today announced ... 2009 Technology Leadership Series seminar. Entitled, "Let,s Talk ... the seminar will feature industry-leading experts and healthcare providers. ...
... 30 seconds of ringtone linked to 25% drop in test ... As if folks needed another reason to be annoyed at ... seconds of a stranger,s nearby ringtone can impair thinking, at ... saw their test scores sink after a fellow "student,s" phone ...
... five therapeutic areas , , Expanding indications for strong ... global capabilities and reach drives growth efforts in emerging markets , ... medicine , , Company,s vision focuses on improving human ... BRUNSWICK, N.J., June 4 Johnson & Johnson (NYSE: ...
... , , , Proven Interoperability ... Hologic, Kodak Carestream, Intergy RIS, Cloverleaf, Meditech RIS, ... CHARLOTTE, N.C., June 4 Healthcare IT workflow ... generation of its comprehensive suite of Enterprise digital ...
... was released today by 1st Class Kids: , ... to raise money in support of continued obesity research ... with TopGolf Skills Challenges, game play, live entertainment, information ... need to raise awareness about childhood obesity. Additionally, there ...
Cached Medicine News:Health News:Best Practices for Hospitals Moving to Electronic Medical Records 2Health News:GTSI to Spotlight Key Trends in Health IT at its June 17 Technology Leadership Series Seminar 2Health News:GTSI to Spotlight Key Trends in Health IT at its June 17 Technology Leadership Series Seminar 3Health News:Stranger's Cell Phone Ring May Thwart Your Thinking 2Health News:Stranger's Cell Phone Ring May Thwart Your Thinking 3Health News:Johnson & Johnson Highlights Pharmaceutical Growth Strategies and Robust Pipeline to Address Unmet Medical Needs 2Health News:Johnson & Johnson Highlights Pharmaceutical Growth Strategies and Robust Pipeline to Address Unmet Medical Needs 3Health News:Johnson & Johnson Highlights Pharmaceutical Growth Strategies and Robust Pipeline to Address Unmet Medical Needs 4Health News:Johnson & Johnson Highlights Pharmaceutical Growth Strategies and Robust Pipeline to Address Unmet Medical Needs 5Health News:Johnson & Johnson Highlights Pharmaceutical Growth Strategies and Robust Pipeline to Address Unmet Medical Needs 6Health News:Johnson & Johnson Highlights Pharmaceutical Growth Strategies and Robust Pipeline to Address Unmet Medical Needs 7Health News:Compressus Delivers Imaging Productivity & Efficiency Improvements in Next Generation MEDxConnect(TM) Workflow Management Solution 2Health News:Compressus Delivers Imaging Productivity & Efficiency Improvements in Next Generation MEDxConnect(TM) Workflow Management Solution 3Health News:Compressus Delivers Imaging Productivity & Efficiency Improvements in Next Generation MEDxConnect(TM) Workflow Management Solution 4
... OraQuick is an FDA ... venipuncture whole blood test used ... of HIV-1 infection. This CLIA ... presence of antibodies to HIV-1, ...
... Mononucleosis test is designed to detect ... plasma or whole blood. The QuickVue+ ... of bovine erythrocytes which give a ... extracts prepared from sheep and horse ...
... available point-of-care diagnostic test that can reliably ... A and B. The test uses a ... that assists viral replication by promoting the ... The ZstatFlu substrate is labeled with a ...
The NOW Flu A test is the most frequently adopted rapid flu test on the market today. Testing could not be easier and the results are available in 15 minutes. Now you can focus on the results and tre...
Medicine Products: