MOUNTAIN VIEW, Calif., Sept. 21, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that based on preliminary feedback from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the company expects an opinion recommending against approval of the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity. The formal decision from the CHMP is expected following their October 2012 meeting. If a negative recommendation is issued in October, and depending upon the nature of the objections, the company will either resubmit the MAA at a later date or appeal this decision and request a re-examination by the CHMP.
"We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe," said Peter Tam, president of VIVUS. "We will work closely with the CHMP to address the Committee's concerns. VIVUS is committed to making this important medication available to obese patients in Europe."
About 50% of adult Europeans are obese or overweight and there are limited treatment options in Europe to address this high unmet medical need. Qsiva was approved by the FDA in July 2012 and was recently launched in the United States under the trade name Qsymia™. Qsiva was studied in over 3,500 patients over 56 weeks establishing it as a safe and effective treatment for obesity.About Qsymia Qsymia ™ (pronounced Kyoo sim ee' uh) 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. Important Safety Information Qsymia (phentermine and topiramate extended-release) capsules CIV must not be used by women who are pregnant; by patients with eye problems (glaucoma); by patients who have been told they have an overactive thyroid; by patients taking a type of anti-depressant called MAOI; or by patients who are allergic to phentermine, topiramate, or any of the ingredients in Qsymia.