Vivus Unveils Qsymia Study Results - Analyst Blog

By Zacks | February 07, 2013 AAA

Vivus Inc. (VVUS) recently announced the publication of results from a study regarding its weight-loss drug, Qsymia. Results from the study revealed that the weight loss arising from treatment with Qsymia capsules CIV significantly reduced cholesterol, blood pressure and triglycerides levels in obese and overweight patients affected by one or more of these associated conditions. Data from the study further revealed that significantly greater improvements were observed in patients who lost at least 10% of their initial weight following treatment with Qsymia. The primary endpoints of the study were percentage weight loss and the proportion of patients who underwent at least 5% weight loss after taking the drug. Data also revealed that treatment with Qsymia resulted in significantly greater dose-related mean percentage weight loss as opposed to placebo in the subgroups of patients suffering from dyslipidemia and hypertension.

We note that the drug is already available in the US. Qsymia was approved by the US Food and Drug Administration (FDA) in Jul 2012. The FDA cleared Qsymia as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese (Body Mass Index, or BMI - 30 or more) or overweight (BMI - 27 or more) adults suffering from at least one weight-related co-morbid condition.

However the drug is yet to found favor with the European regulatory authorities. In Oct 2012, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) did not recommend the approval of Qsiva (proposed trade name of the drug in Europe).

We remind investors that apart from Qsymia, another weight-loss drug, Arena Pharmaceuticals, Inc.'s (ARNA) Belviq, also received approval last year.

Vivus, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma stocks, such as Peregrine Pharmaceuticals, Inc. (PPHM) and Targacept, Inc. (TRGT) are much more favorably placed and carry a Zacks Rank #1 (Strong Buy).

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