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Patients on Qnexa Achieve Average Weight Loss up to 14.7%

Posted by admin | Posted in Weight Loss | Posted on 13-09-2009

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Here some real News to those of you that have a fight with the weight, as you know we only post stuff here which is News worthy.

MOUNTAIN VIEW, Calif., Sept 09, 2009 /PRNewswire-FirstCall via COMTEX News Network/ — VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.

Key Data

Highlights from the EQUIP and CONQUER studies include:

    --  Average weight loss of 14.7% (37 lbs) was achieved by patients treated
        with Qnexa for 56 weeks in the EQUIP study;
    --  Significant improvements in cardiovascular, metabolic and inflammatory
        risk factors among patients treated with Qnexa;
    --  FDA efficacy benchmarks for weight loss agents exceeded at all three
        doses of Qnexa tested in the clinical program;
    --  Completion rates up to 69% were significantly higher than placebo at all
        three doses of Qnexa, indicating favorable tolerability; and

    --  Favorable benefit/risk safety profile for Qnexa.

“The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA,” stated Leland Wilson, president and chief executive officer of VIVUS. “The results of the phase 3 program, designed and executed after Special Protocol Assessments were completed by the FDA, exceed the FDA benchmarks for clinically significant weight loss. The results support the company’s plan to file a New Drug Application with the FDA by the end of 2009 and submit the results from the studies for publication in peer-reviewed journals. We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand.”

Wilson added, “We are proud of the results of our Qnexa phase 3 program, and I would like to thank Dr. Thomas Najarian, the inventor of Qnexa, the entire development team at VIVUS, Dr. David Orloff and his staff at Medpace, the clinical research organization that managed these studies, and the clinical investigators and patients who participated in the Qnexa clinical trials.”

Qnexa is a proprietary formulation and unique dosing regimen that combines two well known pharmaceutical therapies – phentermine and topiramate – to create a novel, patented therapy. The phase 3 program evaluated three doses of Qnexa (numbers reflect milligrams of phentermine and controlled release topiramate, respectively):

Company Vivus

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Patients on Qnexa Achieve Average Weight Loss up to 14.7%9.3103

Comments (2)

maybe the first real diet pill, sounds good.

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but people could also just begin thinking about what they eat, then obesity would not be a problem.

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