November 04, 2011
NDA Accepted for Qnexa for ObesityVivus announced that the FDA has accepted for filing and review the New Drug Application (NDA) for Qnexa (phentermine and topiramate) for the treatment of obesity. The NDA resubmission seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI >30kg/m2), or overweight patients (BMI >27kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity. The proposed labeling includes a contraindication for women of childbearing potential. The resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
Phase 3 data from the 56-week, randomized, double-blind, placebo-controlled, 3-arm, prospective EQUIP study was also presented by Vivus. EQUIP evaluated the efficacy of Qnexa in 1,267 severely patients. Primary efficacy analyses included pre-specified Intent-to-Treat with Last Observation Carried Forward (ITT-LOCF). In addition to average weight loss of 14.4% of initial body weight among those who completed the study at the top dose of Qnexa, severely obese patients had improvements in blood pressure, glucose, triglycerides and cholesterol. In the ITT-LOCF analysis, Least squares mean percent weight loss at week 56 was 10.9% and 5.1% for the top and low dose, respectively, as compared to 1.6% for the placebo group (P<0.0001). Among patients who completed the top-dose course of treatment, 83.5% lost ≥5%; 67.7% lost ≥10%; and 48.1% lost ≥15% of their baseline weight.
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