VIVUS, Inc. (Nasdaq: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010. In previously announced pivotal phase 3 trials, patients treated with all three doses of Qnexa achieved significant weight loss compared to placebo, and significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular, inflammatory and metabolic risk factors.
"The FDA's acceptance of the Qnexa NDA marks an important milestone in the development of Qnexa as a treatment for patients who are obese or overweight with co-morbidities," stated Leland F. Wilson, chief executive officer for VIVUS. "We believe that Qnexa, if approved, will play an important role in treating the millions of patients living with obesity and related diseases, and who are in need of safe and effective options."
SOURCE VIVUS, Inc.