Vivus announced that the FDA has approved Qsymia (phentermine and topiramate extended-release) capsules 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 (obese), or >27 (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia).
Qsymia (formerly known as Qnexa) is the first once-daily combination treatment for obesity management. Vivus was required by the FDA to change the name of its product from Qnexa to Qsymia in order to avoid confusion with other similar-sounding drug names. It is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug. Topiramate is thought to affect both appetite suppression and satiety enhancement. 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 15mg/92mg and 1.6% for placebo (p<0.0001). The average weight loss in CONQUER was 9.8% on Qsymia 15mg/92mg, 7.8% on Qsymia 7.5mg/46mg and 1.2% for placebo (p<0.0001).
Qsymia was approved with a Risk Evaluation and Mitigation Strategy (REMS) informing prescribers and female patients of reproductive potential about an increased risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy.
Qsymia (Schedule C-IV) will be available in 3.75mg/23mg, 7.5mg/46mg, 11.25mg/69mg, and 15mg/92mg dosage strength capsules in the fourth quarter of 2012.
For more information call (650) 934-5200or visit www.Qsymia.com.