MOUNTAIN VIEW, Calif., Sept. 21 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced positive top-line results from a two-year study of QNEXA® (phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans.
The findings come from the SEQUEL study (OB-305), a 52-week extension study for a subset of patients who completed the previously reported 56-week CONQUER study. The total study period was 108 weeks. SEQUEL included 675 obese or overweight patients, all of whom had two or more weight related co-morbidities, and an average baseline BMI of 36.1.
Patients in the study taking the top dose of QNEXA achieved and maintained average weight loss through two years of 11.4% of their initial body weight, or 26 pounds (ITT-LOCF). Consistent with the first year experience, QNEXA therapy was well tolerated, with no new or unexpected adverse events. The most common side effects seen were constipation, tingling, dry mouth, altered taste and insomnia.
Weight loss with QNEXA in SEQUEL was associated with statistically significant improvements in weight-related co-morbidities such as hypertension, dyslipidemia and diabetes. Among patients without diabetes at baseline, the incidence of new onset of type 2 diabetes was reduced by 54% and 76% (mid- and top-dose, respectively) as compared to placebo.
SEQUEL was a double-blind, placebo-controlled, three-arm, prospective study. Patients continued receiving the same treatment they had been randomized to in the CONQUER study in a blinded fashion: either once-a-day treatment with top-dose QNEXA (n=295), mid-dose QNEXA (n=153), or placebo (n=227). Throughout the 108-week treatment period, all patients were advised to follow a simple lifestyle modification program including reduction of food intake by
|SOURCE VIVUS, Inc.|
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