MOUNTAIN VIEW, Calif. Vivus, a biopharmaceutical company focused on unmet needs in obesity, diabetes and sexual health, announced Tuesday that it has filed a New Drug Application to the Food and Drug Administration for approval of Qnexa, a new, investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with such co-morbidities as hypertension, Type 2 diabetes, dyslipidemia or central adiposity.
The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two, 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 FDA Guidance for Developing Products for Weight Management, the company stated. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors, according to the study.
"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," noted Leland Wilson, CEO, Vivus. "The weight loss of up to 14.7% (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."
According to Vivus, other highlights from the two 56-week EQUIP and CONQUER studies — which comprised more than 3,750 patients — included:
- Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;
- FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;
- Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and
- Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.