Biopharmaceutical company Vivus, Inc. (VVUS) on Tuesday said its weight-loss drug Qsymia is available in the U.S. market.
Once Daily Qsymia Capsules CIV is approved by FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater, or 27 or greater in the presence of at least one weight-related comorbidity. These include hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia).
The company noted that the drug is the first FDA-approved once daily combination therapy - and the first new medication available in 13 years - for the treatment of obesity. Qsymia has shown to achieve an average weight loss of 10% in obese patients when used in conjunction with a lifestyle modification program, the company noted.
The safety and efficacy of Qsymia were evaluated in two multicenter, phase 3 trials that included more than 3,700 patients.
VIVUS will formally introduce Qsymia to medical professionals this week at The Obesity Society's Annual Scientific Meeting in San Antonio, Texas.
VIVUS has also introduced the Qsymia Risk Evaluation and Mitigation Strategy program, which includes a Medication Guide, healthcare provider training, patient brochure and other education tools. As part of the program, Qsymia is available only through certified mail order pharmacies that are part of the Qsymia Home Delivery Network including CVS Pharmacy and Walgreens.
"With the availability of this new therapeutic option, Americans struggling with obesity finally have another important tool to help address their weight and related co-morbidities," added Joe Nadglowski, Obesity Action Coalition President and CEO.
In pre-market activity, VIVUS shares are currently trading at $23.10, up $0.17 or 0.74 percent.
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