MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has successfully concluded communications with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process regarding key elements of the pivotal phase 3 clinical trials of Qnexa for the treatment of obesity and weight-related co-morbidities. 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.
