Pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has completed enrollment in the EQUATE study (OB-301). This trial, initiated in December 2007, will study the effects of Qnexa, an investigational drug, in obese patients with and without co-morbidities over 28 weeks. The EQUATE study has enrolled over 700 patients with Body Mass Index (“BMI”) ranging from 30 to 45 in 35 clinical sites. The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more.

Patients in the EQUATE study will undergo a 4-week dose titration period followed by 24 weeks of treatment. The study is a randomized, double-blind, placebo-controlled, 7-arm, prospective trial with subjects randomize to receive once-a-day treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate CR), full strength Qnexa (15 mg phentermine/92 mg topiramate CR), the respective phentermine and topiramate constituents, or placebo. At randomization, subjects will be instructed to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program throughout the study period. VIVUS has completed the Special Protocol Assessment (“SPA”) process for this trial with the U.S. Food and Drug Administration (FDA). Under the SPA process, the company and the FDA have reached agreement on study design features that will be employed throughout the entire phase 3 program including the co-primary endpoints of the study, scope and size of the patient population, specific safety assessments, inclusion/exclusion criteria, duration of the trials and the statistical method for analyzing the co-primary study endpoints.