VIVUS Inc. (VVUS) announced that the U.S. Food and Drug Administration has approved weight loss drug Qsymia. It is expected that Qsymia will be available in the fourth quarter of 2012.
FDA approved Qsymia as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 or greater, or 27 or greater in the presence of at least one weight-related comorbidity,
The most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth, the company noted.
As part of the approval of Qsymia, VIVUS is committed to conduct post-marketing studies.
Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.
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