VIVUS PRESENTS DATA ON OBESITY TREATMENT

Vivus has presented positive results from a Phase II clinical trial of Qnexa (formerly VI-0521), an investigational oral treatment for obesity. When compared to those on placebo, patients treated with Qnexa experienced a statistically significant average weight loss and a reduction in waist circumference. Significant reductions were also seen in lipid levels despite normal mean baseline values. The dropout rate for the trial was 8 percent in the Qnexa arm, compared with 38 percent in the placebo arm.

The Phase II study was a double-blind, randomized, placebo-controlled trial conducted at Duke University. This trial involved 200 subjects, 159 women and 41 men, with an average age of 40 and a mean body mass index (BMI) of 38.6. A BMI greater than 30.0 is classified as obese in HHS guidelines.

Patients completing the 24-week treated period achieved a highly significant average weight loss of 26.0 pounds, compared with 7.0 pounds for the placebo group. Using an intent-to-treat, last observation-carried forward (ITT-LOCF) analysis, treatment with Qnexa had a highly significant average weight loss of 25.1 pounds, compared with 4.8 pounds for the placebo group. The study completion rate for patients on Qnexa over the 24-week treatment period was 92 percent, compared with 62 percent for patients in the placebo group.

Qnexa is a proprietary pharmaceutical treatment that incorporates low doses of active ingredients from two previously approved products (phentermine and topiramate). By combining the activity of each of these compounds, Qnexa simultaneously addresses excessive appetite and high threshold for satiety, the two main mechanisms that influence eating behavior, according to the company.