We have conducted a one-year extension study of a subset of patients who have completed the 56-week CONQUER study.  The SEQUEL study is a double-blind, placebo-controlled, 3-arm, prospective study across 36 centers comparing Qnexa to placebo over an additional 52-week treatment period.  Patients in SEQUEL continued receiving the same treatment they had been receiving, in a blinded fashion, from the CONQUER study.  The co-primary endpoints for this study are the differences between treatments in weight loss and percent weight loss from the beginning of the CONQUER trial to the end of the treatment period.  Patients were asked to continue a hypocaloric diet representing a 500-calorie/day deficit and were advised to follow a simple lifestyle modification program.

SEQUEL enrolled approximately 650 obese or overweight patients with a BMI that equaled or exceeded 22 kg/m2 with controlled co-morbidities.  Patients were followed for 52 weeks of treatment with patients continuing in their respective CONQUER treatment group receiving either once-a-day treatment with mid-dose Qnexa, full-dose Qnexa or placebo.  This extension study was not required by the FDA nor did it need to be completed in support of the NDA for Qnexa for the treatment of obesity.  The purpose of this study is to support the Marketing Authorization Application, or MAA, filing in Europe.  The results of the SEQUEL study are expected before the end of the third quarter of 2010.

"Several presentations on Qnexa at various medical conferences continued our commitment to share our results with healthcare professionals.  On the regulatory front, we continue to work with the FDA to address the items discussed at the recent Advisory Committee meeting.  The two-year data from the SEQUEL study will provide information on the long-term efficacy and safety of Qnexa.  We look forward to working with the FDA as we approach the PDUFA date on October 28, 2010," stated Leland Wilson, chief executive officer of VIVUS.  "In the second quarter of 2010 we continued the advancement of avanafil.  The results of the REVIVE-Diabetes study showed avanafil treatment was successful in improving erectile function in men with diabetes.  The results were consistent with those observed in the first phase 3 study in men with ED from a general population."

SOURCE VIVUS, Inc.