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Results From Phase 3 EQUATE Trial of VIVUS' Qnexa Highlighted at European Congress on Obesity
Date:5/7/2009

ing patients who have struggled unsuccessfully to lose weight for years."

The proportion of Qnexa patients losing 5 percent or more of their initial body weight was 66 percent for full-dose, 62 percent for mid-dose and 15 percent for placebo. The proportion of Qnexa patients losing 10 percent or more of their initial body weight was 41 percent for full-dose, 39 percent for mid-dose and 7 percent for placebo.

Qnexa was well-tolerated, with no drug-related serious adverse events in the study. The most common adverse events reported for the full-dose, mid-dose and placebo group were tingling (23%, 16%, 3%), dry mouth (18%, 13%, 0%), headache (16%, 15%, 13%), and constipation (15%, 7%, 8%). The completion rate for the study overall was 70 percent.

"The weight loss seen across our phase 2 and phase 3 obesity and diabetes Qnexa trials to date, coupled with the positive impact observed on other cardiometabolic factors such as blood pressure, cholesterol and glucose, is impressive and potentially represents a step forward in the treatment of obesity and obesity-related conditions," commented Leland Wilson, president and chief executive officer of VIVUS. "We are delighted to see these data - the first of our three phase 3 clinical trials evaluating Qnexa for obesity - highlighted at ECO."

In addition to EQUATE, the phase 3 Qnexa program includes two double-blind, placebo-controlled, multi-center studies that will compare Qnexa to placebo during a 56-week treatment period. The first year-long study, known as EQUIP (OB-302), enrolled morbidly obese patients with a Body Mass Index (BMI) of 35 or greater. The second year-long trial, known as CONQUER (OB-303), enrolled overweight and obese adult patients with BMIs from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes. The co-primary endpoints for these studies are the mean percent weight loss and the per
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SOURCE VIVUS, Inc.
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