Vivus initiates second pivotal Phase III trial for treatment of obesity

The co-primary endpoints for these studies will evaluate the differences between treatments from baseline to the end of the treatment period, in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more.

The Conquer study will enroll approximately 2,500 subjects in up to 120 centers. Patients will undergo a 4-week dose escalation period followed by 52 weeks of treatment. The study is a randomized, double-blind, placebo-controlled prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5mg phentermine/46mg topiramate) or full strength Qnexa (15mg phentermine/92mg topiramate) or placebo. Randomization will be stratified by gender and diabetic status, and at least 20% of the subjects will be male.

At randomization, subjects will be instructed to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a lifestyle modification program throughout the study period. Vivus has completed the special protocol assessment process for this trial with the FDA.

Arthur Frank, chairman of the Qnexa scientific advisory board for Vivus, said: “Qnexa is a potentially important new treatment alternative for obese patients who are coping with serious weight-related medical conditions. In the Phase II studies, patients treated with Qnexa were able to achieve the level of weight loss, and improvement in lipids, blood pressure and other risk factors that suggest a substantial potential for benefit in the Conquer study”.