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All Phase 3 Trials Fully Enrolled Ahead of Schedule
MOUNTAIN VIEW, Calif., USA | Apr 22, 2008 | VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has completed enrollment in the final of three phase 3 studies of Qnexa(TM) in overweight and obese patients with co-morbidities including hypertension, dyslipidemia, or type 2 diabetes. The CONQUER study (OB-303) enrolled patients with a Body Mass Index ("BMI") ranging from 27 to 45 and at least two additional co-morbidities. The co-primary endpoints for this study are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.
"Obesity is a major epidemic that significantly contributes to early death due to cardiovascular disease, diabetes, and cancer. Our phase 3 program is designed to evaluate weight loss in these patients and potential benefit on their co-morbidities," commented Leland Wilson, president and chief executive officer at VIVUS. "Completing enrollment for a 4,500-patient phase 3 program ahead of schedule is a major accomplishment for our development team at VIVUS. We are now poised to complete these studies by the middle of next year."
About the CONQUER study
In the CONQUER study, approximately 2,500 subjects will be treated at approximately 93 centers throughout the United States. Patients undergo a 4-week dose escalation period followed by 52 weeks of treatment. The study is a randomized, double blind, placebo-controlled prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate CR), full strength Qnexa (15 mg phentermine/92 mg topiramate CR) or placebo. Randomization is stratified by gender and diabetic status, and at least 20% of the subjects are male. Subjects are instructed to follow a simple diet and lifestyle modification program throughout the study. VIVUS has completed the Special Protocol Assessment ("SPA") process for this trial with the U.S. Food and Drug Administration (FDA). Under the SPA process, the Company and the FDA reached agreement on study design features that will be employed throughout the entire phase 3 program, including the co-primary endpoints of the study, scope and size of the patient population, specific safety assessments, inclusion/exclusion criteria, duration of the trials and the statistical method for analyzing the co-primary study endpoints. More information about the trial can be found at www.clinicaltrials.gov.
About the Phase 3 Program
The phase 3 Qnexa program includes two pivotal, double blind, placebo-controlled, multi-center studies in distinct populations that will compare Qnexa to placebo during a 56-week treatment period. The studies are designed to prospectively demonstrate the safety and efficacy of Qnexa. The first study, known as EQUIP (OB-302), has enrolled approximately 1,250 morbidly obese adult subjects with a Body Mass Index ("BMI") of 35 or greater with or without controlled co-morbidities. The second trial, known as CONQUER (OB-303), has enrolled overweight and obese adult subjects with BMI's from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.
The phase 3 program also includes a six-month confirmatory factorial study, known as EQUATE (OB-301), in obese subjects with BMI's from 30 to 45. This trial is designed to evaluate two dose levels of Qnexa, compared to placebo and the individual constituents in Qnexa. The primary endpoints will be similar to those evaluated in the pivotal studies.
Safety and tolerability of Qnexa will be determined by reports of adverse events, physical exam, clinical laboratory data, electrocardiogram, cognitive function tests, psychological assessments, and clinical assessment of clinical laboratory variables. The phase 3 program has enrolled approximately 4,500 subjects.
SOURCE: VIVUS, Inc. |
