VIVUS, Inc. (NASDAQ: VVUS) today 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).
"Qsymia is the first FDA-approved once daily combination treatment for patients struggling with obesity," said Peter Tam, President of VIVUS. "The degree and severity of obesity and the lack of effective pharmacological interventions that we face as a society were two primary reasons for the development of Qsymia. We are pleased with FDA's decision today because patients and physicians now have another treatment option available to them. It is expected that Qsymia will be available in the fourth quarter of 2012."
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.
Qsymia was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of 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, the importance of pregnancy prevention for females of reproductive potential receiving Qsymia and the need to discontinue Qsymia immediately if pregnancy occurs. The Qsymia REMS program includes a Medication Guide, Healthcare Provider training, distribution through certified pharmacies, implementation system and a time table for assessments.
As part of the approval of Qsymia, VIVUS is committed to conduct post-marketing studies. The company will conduct a study to assess the long-term treatment effect of Qsymia on the incidence of major adverse cardiovascular events in overweight and obese subjects with confirmed cardiovascular disease, studies to assess the safety and efficacy of Qsymia for weight management in obese pediatric and adolescent subjects, studies to assess drug utilization and pregnancy exposure, a study to assess renal function, as well as animal and in vitro studies.