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MOUNTAIN VIEW, Calif., Sept. 20, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced it has submitted to the European Medicines Agency (EMA) a request for scientific advice regarding use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial (CVOT) to support the resubmission of the marketing authorization application (MAA) for approval in Europe of Qsiva™ for obesity under the centralized procedure. In order to accommodate advice from the European authorities, VIVUS anticipates that patient enrollment for the AQCLAIM study will commence in first quarter 2014.
"Our plan is on track to maximize the value of Qsiva in Europe and we believe that leveraging the AQCLAIM CVOT data is a prudent and scientifically sound approach, guided by our European senior advisors," said Seth Fischer, CEO of VIVUS. "We look forward to working with the European authorities to bring Qsiva to patients suffering from obesity and related comorbidities."
The AQCLAIM (A Qsymia CardiovascuLAr morbIdity and Mortality) study is a randomized, double-blind, placebo-controlled multicenter clinical trial designed to assess the long-term treatment effect of Qsymia on the incidence of major adverse cardiovascular events in overweight and obese subjects with confirmed cardiovascular disease. This study is among the postmarketing requirements determined by FDA in conjunction with the approval of Qsymia.
Qsiva is marketed in the U.S. under the brand name Qsymia
®. Qsymia (phentermine and topiramate extended-release) capsules CIV is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m
2 or greater (obese) or 27 kg/m
2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.