Vivus Inc Announces FDA Approval of Once Daily Qsymia (Phentermine and Topiramate Extended-release) Capsules CIV

Vivus Inc announced that the U.S. Food and Drug Administration (FDA) has approved Qsymia (pronounced Kyoo sim ee' uh) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). The safety and efficacy of Qsymia were evaluated in two multicenter, phase 3 trials that included severely obese patients (the EQUIP study), and overweight or obese patients with at least two weight-related comorbidities, such as hypertension, hypertriglyceridemia, type 2 diabetes, or central adiposity (the CONQUER study). The average weight loss in EQUIP was 10.9% on Qsymia 15 mg/92 mg and 1.6% for placebo (ITT-LOCF, p<0.0001). The average weight loss in CONQUER was 9.8% on Qsymia 15 mg/92 mg, 7.8% on Qsymia 7.5 mg/46 mg and 1.2% for placebo (ITT-LOCF, p<0.0001). The most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.