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

in the United States and many developed countries. I wish to thank all of the VIVUS employees, contractors and advisors who contributed to the program and made this on-time filing possible."

Previously reported highlights from the two 56-week EQUIP and CONQUER studies comprising more than 3,750 patients include:

  • Weight loss of up to 14.7% (37 lbs) achieved by patients treated with Qnexa for 56 weeks in the EQUIP study;
  • Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;
  • FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;
  • Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and
  • Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.

About the Phase 3 Program

The phase 3 clinical program, evaluating Qnexa in more than 4,500 patients, was designed under a Special Protocol Assessment with the U.S. FDA and consists of three trials: EQUATE (OB-301), EQUIP (OB-302) and CONQUER (OB-303). The EQUATE study was a 28-week randomized, double-blind, placebo-controlled, 7-arm, prospective trial with subjects randomized to receive once-a-day treatment with mid- or full-dose Qnexa, the respective constituents, or placebo. The average baseline BMI of the study population was 36.3 kg/m(2) with an average baseline weight of 223 pounds. The EQUIP and CONQUER studies were 56-week, randomized, double-blind, placebo-controlled, 3-arm, prospective trials with patients randomized to receive once-a-day treatment with low-, mid-, or full-dose Qnexa, or placebo. In EQUIP, the average baseline BMI of the study population was 42.1 kg/m(2) with an av
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SOURCE VIVUS, Inc.
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