Vivus has resubmitted its New Drug Application (NDA) for Qnexa (phentermine and topiramate). The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI ≥30kg/m2), or overweight patients (BMI ≥27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity. The proposed labeling for Qnexa includes a contraindication for women of childbearing potential. The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety – the two main mechanisms that impact eating behavior – in one capsule. In Phase 2 and 3 clinical studies, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors.
For more information call (650) 934-5200 or visit www.vivus.com.