Vivus Submits Qnexa New Drug Application to the FDA for the Treatment of Obesity

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MOUNTAIN VIEW, Calif., Dec. 29 /PRNewswire-FirstCall/ -- Vivus, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the

treatment of obesity, including weight lossand maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two pivotal, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors."This NDA filing is a major milestone for Vivus and the Qnexa program. The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or

overweight with co-morbidities," stated Leland F. , chief executive officer for Vivus. "The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries. I wish to thank all of the Vivus employees, contractors and advisors who contributed to the program and made this on-time filing possible."Previously reported highlights from the two 56-week EQUIP and CONQUER studies comprising more than 3,750 patients include:Weight loss of up to 14.7% (37 lbs) achieved by patients treated with Qnexa for 56 weeks in the EQUIP study;Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; andAcross both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.About the Phase 3 ProgramThe phase 3 clinical program, evaluating Qnexa in more than 4,500 patients, was designed under a Special Protocol Assessment with the U.S. FDA and consists of three trials: EQUATE (OB-301), EQUIP (OB-302) and CONQUER (OB-303). The EQUATE study was a 28-week randomized, double-blind, placebo-controlled, 7-arm, prospective trial with subjects randomized to receive once-a-day treatment with mid- or full-dose Qnexa, the respective constituents, or placebo. The average baseline BMI of the study population was 36.3 kg/m(2) with an average baseline weight of 223 pounds. The EQUIP and CONQUER studies were 56-week, randomized, double-blind,

placebo-controlled, 3-arm, prospective trials with patients randomized to receive once-a-day treatment with low-, mid-, or full-dose Qnexa, or placebo. In EQUIP, the average baseline BMI of the study population was 42.1 kg/m(2) with an average baseline weight of 256 pounds; in CONQUER, the average baseline BMI of the study population was 36.6 kg/m(2) with an average baseline weight of 227 pounds. All patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program.About QnexaQnexa (Q-NEX-uh) is an investigational drug being developed to address weight loss. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety - the two main mechanisms that impact eating behavior - in one capsule. In phase 2 and 3 clinical studies, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular riskfactors.http://www.drugs.com/nda/qnexa_091229.html?utm_source=feedburner & utm_medium=feed & utm_campaign=Feed:+Drugscom-NewDrugApplications+(Drugs.com+-+New+Drug+Applications) & utm_content=Google+Feedfetcher?printable=1 Regards, Vergelpowerusa dot org