Vivus, Inc, a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced that a New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type-2 diabetes, dyslipidemia or central adiposity.
The NDA submission follows the successful completion of the phase-3 programme for Qnexa, including the recently announced results from the two pivotal, year-long phase-3 studies, Equip and Conquer. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current US FDA Guidance for Developing Products for Weight Management. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors.
"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 per cent (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."
Qnexa (Q-NEX-uh) is an investigational drug being developed to address weight loss.
Vivus is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health.