Vivus Inc. said Tuesday it submitted a New Drug Application to the Food and Drug Administration seeking approval of Qnexa, its investigational drug for the treatment of obesity.
Mountain View-based Vivus (NASDAQ:VVUS) said Qnexa also may be used for maintenance of weight loss in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.
The NDA submission follows the successful completion of the Phase 3 program for Qnexa. Vivus said patients treated with all three doses of Qnexa "achieved significant percent and categorical weight loss compared to placebo" and met regulatory requirements for weight loss products
Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors, Vivus said.