"This NDA filing is a major milestone for VIVUS and the Qnexa program. The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities," stated Leland F. Wilson, chief executive officer for VIVUS. "The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries. I wish to thank all of the VIVUS employees, contractors and advisors who contributed to the program and made this on-time filing possible."

Previously reported highlights from the two 56-week EQUIP and CONQUER studies comprising more than 3,750 patients include:

Weight loss of up to 14.7% (37 lbs) achieved by patients treated with Qnexa for 56 weeks in the EQUIP study; Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa; FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program; Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.SOURCE VIVUS, Inc.