Supplier News Breaks Archives
VIVUS gets FDA OK for obesity drug
July 18th, 2012
MOUNTAIN VIEW, Calif. – VIVUS Inc. has been cleared by the Food and Drug Administration to market Qsymia, a weight-loss pill aimed at adults struggling with obesity and related health conditions.
The company said late Tuesday that the combination weight management medication (phentermine and topiramate extended-release) is the first of its kind and is expected to become available in the fourth quarter.
Qsymia is indicated as an adjunct to a reduced-calorie diet and exercise for chronic weight management in adults with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) and who have at least one weight-related comorbidity, such as hypertension, type 2 diabetes or high cholesterol (dyslipidemia).
"Qsymia is the first FDA-approved, once-daily combination treatment for patients struggling with obesity," stated Peter Tam, president of VIVUS. "The degree and severity of obesity and the lack of effective pharmacological interventions that we face as a society were two primary reasons for the development of Qsymia. We are pleased with FDA's decision today because patients and physicians now have another treatment option available to them."
The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients.
VIVUS said that Qsymia demonstrated effective weight loss in two phase 3 trials. One trial with severely obese patients yielded an average weight loss of 10.9% on Qsymia 15 mg/92 mg and 1.6% for the placebo. In the other trial, involving overweight or obese patients with at least two weight-related comorbidities (such as hypertension, hypertriglyceridemia, type 2 diabetes or central adiposity), the average weight loss was 9.8% on Qsymia 15 mg/92 mg, 7.8% on Qsymia 7.5 mg/46 mg and 1.2% for the placebo.