Qsymia Once-Daily Capsules Available for Obesity in U.S.
First new drug for this indication in 13 years (Sept. 18)
Vivus, Inc., based in Mountain View, Calif., announced on September 18 that Qsymia (phentermine and topiramate) extended-release capsules are available in the U.S. market.
Qsymia was approved by the FDA 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 with a BMI of 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). It is the first FDA-approved once-daily combination drug — and the first new medication available in 13 years — for the treatment of obesity.
Vivus will formally introduce Qsymia to medical professionals at the Obesity Society's Annual Scientific Meeting, which will be held on September 20–24 in San Antonio, Texas.
The safety and efficacy of Qsymia were evaluated in two phase III trials that included more than 3,700 patients: 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 the EQUIP trial was 10.9% for Qsymia 15 mg/92 mg and 1.6% for placebo (P < 0.0001). The average weight loss in the CONQUER trial was 9.8% for Qsymia 15 mg/92 mg, 7.8% for Qsymia 7.5 mg/46 mg, and 1.2% for placebo (P < 0.0001).
The most common adverse reactions in patients treated with Qsymia included a tingling sensation in the hands and feet, dizziness, altered taste, insomnia, constipation, and dry mouth.
Vivus is emphasizing its Risk Evaluation and Mitigation Strategy (REMS) program for Qsymia, which is intended to inform prescribers and female patients of reproductive age about the following: 1) an increased risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy; 2) the importance of pregnancy prevention for females of reproductive age receiving Qsymia; and 3) the need to discontinue Qsymia immediately if pregnancy occurs.
For more information, visit the Vivus, Inc. Web site.