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:11/21/2014)... Nov. 20, 2014   Coqui RadioPharmaceuticals Corp. , ... U.S. commercial producer of Molybdenum-99 (Mo-99), is proud to ... INVAP to design its Medical Isotope Production Facility ... is the parent isotope of Technetium-99, which is used ... 2012, Congress passed legislation making it a national priority ...
(Date:11/21/2014)... --  Wellcentive , the industry leader in end-to-end ... today being named one of the four finalists ...  Sponsored by Intel, the world leader in computing ... companies developing leading-edge technology and unique approaches to ... Wellcentive,s Mason Beard , senior vice ...
(Date:11/21/2014)... 2014  Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ... of $80,000,000 aggregate principal amount of 5.25% Convertible Senior ... offering within the United States . ... pursuant to Rule 144A under the Securities Act of ... granted the initial purchasers an option to purchase up ...
Breaking Medicine Technology:Coqui RadioPharmaceuticals Inks Deal With INVAP 2Wellcentive Named Finalist for 2014 Intel Innovation Award 2Wellcentive Named Finalist for 2014 Intel Innovation Award 3Lexicon Announces Pricing Of Convertible Senior Notes Offering 2Lexicon Announces Pricing Of Convertible Senior Notes Offering 3
... SWANTON, Vt ., May 7 This May, AllerAir ... their effort to spread Multiple Chemical Sensitivity Syndrome awareness.   , ... AllerAir will make chemical awareness tips ... www.allerair.com .  Additionally, their blogs and articles ...
... A post-hoc analysis of a Phase 3 safety study ... a lower incidence of nausea, vomiting and constipation when compared ... moderate to severe low-back or osteoarthritis pain.  These data will ... Annual Scientific Meeting of the American Pain Society (APS), and ...
Cached Medicine Technology:Multiple Chemical Sensitivities Are Real 2Multiple Chemical Sensitivities Are Real 3Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 2Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 3Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 4Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 5Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 6Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 7Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 8Data Comparing NUCYNTA(R) (tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented at 2010 American Pain Society Annual Meeting 9
(Date:11/23/2014)... 2014 SWAccessControl.com's high quality access control ... the company has announced its new collection of power ... these high quality power suppliers. All the new models ... special offer lasts until Dec. 20, 2014. , SWAccessControl.com ... have been supporting it for a long time. It ...
(Date:11/23/2014)... Falls Church, VA (PRWEB) November 23, 2014 ... and TV Have in Common, **FDAnews On-Demand Webinar**, Dec. ... http://www.fdanews.com/TheFDAisWatchingOnDemand , The FDA’s focus on promotional ... ads. , Now they're looking at websites, ... , Mark the calendar for Thursday, Dec. 11, for ...
(Date:11/22/2014)... Greenville, SC (PRWEB) November 23, 2014 ... back to their communities. AlignLife experience rapid growth in ... upon a very unique opportunity. AlignLife of Simpsonville ... area AlignLife offices for their first annual Toy Drive. ... local charity they would support with this year's toy ...
(Date:11/22/2014)... A classic black prom dress will never go out of ... unveiled its new items of black prom gowns . ... big discount, up to 70% off. People throughout the world ... prom dresses, made with the best materials, can make wearers ... customers, the company provides these beautiful outfits in a huge ...
(Date:11/22/2014)... (PRWEB) November 22, 2014 “Due to my ... an inventor, from Gurnee, Ill. “While using the ice grip ... and I thought there needed to be a safer way ... the SPIKE BLOCK. , The SPIKE BLOCK offers added safety ... it would help to reduce injuries and damage associated with ...
Breaking Medicine News(10 mins):Health News:Cheap Access Control Power Supplies Online Now at SWAccessControl.com, Special Offer Until Dec. 20, 2014 2Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 2Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 3Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 4Health News:FDAnews Announces The FDA is Watching: What Twitter, Tradeshows and TV Have in Common, On-Demand Webinar, Dec. 11, 2014 5Health News:Greenville Area AlignLife Offices Join Together for a Local Toy Drive 2Health News:New Black Prom Dresses from BellasDress.com 2
... The Cosmetic Bootcamp, LLC,announces that its annual marketing and ... will begin on Dec. 11, 2008. Despite a ... sponsorship.,According to program chair, Kenneth Beer MD, "We are ... for specialists both by the specialists,and industry." Dr. ...
... resource the necessary information to make an informed decision when ... , , LYNDHURST, N.J., Dec. ... city,s best otolaryngologist (and figuring out what an otolaryngologist is), ... if you,re not an MD, a DO or are certified ...
... Phase II Cancer Trials and the Company,s Other Clinical Programs All ... - Significant Validation Achieved for Bavituximab and Peregrine,s Anti-PS Anti-Viral ... - Company Enters into Loan Agreement for Up to ... TUSTIN, Calif., Dec. 10 Peregrine Pharmaceuticals, Inc. (Nasdaq: ...
... PetFit(TM) Challenge Participant Shows Remarkable Quick Weight Loss Improvement , ... On January 20, Zeb, a 104 pound, 7-year-old, Labrador ... Hill,s PetFit(TM) Challenge participants. At Zeb,s recheck on ... lost 22 pounds and was now at 82 pounds. Dr. ...
... dry skin... much of the time with poor results. During Winter, ... the skin. , ... Denver, CO. (PRWEB) December 10, 2008 -- Winter ... across the country suffering from dry skin problems. According to estimates ...
... Global Med Technologies(R), Inc.,("Global Med" or the "Company") (OTC ... today announced that on,Tuesday, December 9, 2008, its board ... LLC ("VPC") whereby VPC proposed to acquire a,majority share ... proposal received is,as follows: , , ...
Cached Medicine News:Health News:Vitals Launches Free eBook to Help Consumers Find 'Dr. Right' 2Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 2Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 3Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 4Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 5Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 6Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 7Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 8Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 9Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 10Health News:Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009 11Health News:Video: Combined Veterinary and Pet Owner Efforts Help Pet Lose Big 2Health News:Video: Combined Veterinary and Pet Owner Efforts Help Pet Lose Big 3Health News:Top Tips To Naturally Heal Dry Skin And Moisturize This Winter 2Health News:Top Tips To Naturally Heal Dry Skin And Moisturize This Winter 3Health News:Global Med Technologies(R) Inc. Receives Unsolicited Proposal From Victory Park Capital Advisors, LLC 2Health News:Global Med Technologies(R) Inc. Receives Unsolicited Proposal From Victory Park Capital Advisors, LLC 3Health News:Global Med Technologies(R) Inc. Receives Unsolicited Proposal From Victory Park Capital Advisors, LLC 4
Cholesterol FS. For determination of cholesterol in serum or plasma. Available with Calibrator: Trucal U and Controls: Trulab N, Trulab P Trulab L....
Intended for the quantitative determination of total cholesterol in serum. Reaction: Endpoint. Reaction complete within five minutes. Wavelength: 500 nm. Linearity: 700 mg/dL (18.1 mmol/L). Single st...
This 16-bit integrated and cooled system is a completely self contained unit built with a long list of standard features including all-electronic-variable transilluminator and EPI lighting....
... SE is a major upgrade ... of important physical and software ... operation and increase efficiency. The ... Generation" ACS:180. The productivity of ...
Medicine Products: