QNEXA therapy was well tolerated, with no new safety signals seen between 56 and 108 weeks. The most common side effects were upper respiratory infection, constipation, tingling, sinus infection, dry mouth and runny nose. Serious adverse event rates over two years were low (mid and top dose 5.9%, 8.1%) and placebo (6.2%), with no drug-related serious adverse events reported. The completion rate in SEQUEL was approximately 83% for both QNEXA doses and 86% for the placebo group. Discontinuations due to adverse events were 4.6% and 4.4% for the mid and top dose, respectively, and 3.1% for the placebo group.
About the SEQUEL Study
SEQUEL (OB-305) was a double-blind, placebo-controlled, three-arm, prospective study. Patients continued receiving the same treatment assignment to which they had been randomized in the CONQUER study in a blinded fashion: either once-daily treatment with top-dose QNEXA (n=295), mid-dose QNEXA (n=153), or placebo (n=227). The SEQUEL study was a 52-week extension study for a subset of patients who completed the 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. Throughout the 108-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day.
About QNEXA Controlled Release CapsulesQNEXA [kyoo- nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program. About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. QNEXA® is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com SOURCE VIVUS, Inc.
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