The Lancet publishes VIVUS 56-week QNEXA study results in obesity

VIVUS, Inc. (NASDAQ: VVUS) today announced that detailed results from the 56-week CONQUER study were published in The Lancet evaluating the efficacy and safety of investigational drug QNEXA in 2,487 patients across 93 sites in the US. Data published in the peer-reviewed journal provided an in-depth look at weight loss and improvements in the full spectrum of co-morbidities studied as secondary endpoints, including cardiovascular, metabolic and inflammatory risk factors.

"Obesity is a serious medical condition associated with increased mortality from cardiovascular diseases, diabetes, cancer and other diseases, yet there is a lack of treatment options for the one-third of American adults who are obese," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and lead investigator. "Half the patients in the study had at least three co-morbidities including diabetes, representing a population with the greatest medical need for weight loss. We observed significant weight loss, improvements in co-morbidities and a reduction in the need for concomitant medications in patients treated with QNEXA."

Specific results for all patients through 56 weeks as published in The Lancet are as follows:

Weight Loss

• Average weight loss for QNEXA patients who completed the CONQUER study on the study drug was 28 pounds and 22 pounds with top-dose QNEXA and mid-dose QNEXA, respectively, compared to 4 pounds in the placebo group;
• In the ITT-LOCF analysis, least-squares mean percent weight loss at week 56 was -7.8% and -9.8%, respectively, for the mid and top dose as compared to -1.2% for the placebo group;
• Categorical weight loss from baseline (ITT-LOCF) was:

Blood Pressure

• Reduction in systolic blood pressure of -4.7 mm Hg
• Reduction in diastolic blood pressure of -3.4 mm Hg
• More patients had a reduction in the number of blood pressure medications with QNEXA treatment compared to placebo.

Lipids

• Improvements in HDL cholesterol of 5.2% (p<0.0001) and 6.8% (p<0.0001), respectively, for the mid and top dose as compared to 1.2% for the placebo group;
• Reduction in LDL cholesterol of -3.7%
• Reduction in triglyceride levels of -8.6% (p<0.0001) and -10.6% (p<0.0001), respectively, for the mid and top dose as compared to an increase of 4.7% for the placebo group.

Metabolic Parameters

• Reduction in fasting insulin of -24.0 pmol/L
• Fewer non-diabetic patients on QNEXA progressed to type 2 diabetes; relative risk (vs placebo) was 0.47 (0.25 – 0.88) with top-dose QNEXA;
• More patients in the placebo group required an increase in the number of antidiabetic drugs than those treated with QNEXA.

More patients completed one year of treatment in the QNEXA groups, mid dose (69%) and top dose (64%) respectively, as compared to 57% in the placebo group. QNEXA therapy was well tolerated, with no unexpected adverse events. The most common side effects were dry mouth, paresthesia (tingling), constipation, insomnia, dizziness and dysgeusia (altered taste). Rates of serious adverse events were similar across treatment groups: 4% with placebo, 3% with mid-dose QNEXA and 5% with top-dose QNEXA. Most adverse events were seen early in treatment and there was a low dropout rate due to adverse events, 12% and 19% for mid and top dose respectively, compared to 9% for placebo.