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MOUNTAIN VIEW, Calif. — VIVUS Inc. has begun rolling out Qsymia, its weight management drug, in the U.S. market.
The company said Tuesday that Qsymia (phentermine and topiramate extended-release) marks the first Food and Drug Administration-approved, once-daily combination therapy for obesity and represents and the first new medication available in 13 years for the condition.
Qsymia is FDA-approved 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 (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes or high cholesterol.
VIVUS said it’ formally introducing Qsymia to medical professionals this week at The Obesity Society’s Annual Scientific Meeting in San Antonio, Texas.
"VIVUS is proud to be leading the way in the treatment of obesity, a disease with very serious health consequences," stated Peter Tam, president of VIVUS. "Qsymia is the first ever combination treatment made available, and today’s introduction marks a new beginning for many patients who struggle with obesity. We are excited about making this new treatment option available to patients because Qsymia is the first FDA-approved oral medication that has been shown to achieve an average weight loss of 10% in obese patients when used in conjunction with a lifestyle modification program."
To help ensure healthcare providers and patients are properly educated, VIVUS said it’s emphasizing the Qsymia Risk Evaluation and Mitigation Strategy (REMS) program, which includes a medication guide, health care provider training, a patient brochure and other education tools.
As part of the REMS program, Qsymia is available only through certified mail order pharmacies that are part of the Qsymia Home Delivery Network, including CVS/pharmacy and Walgreens.
VIVUS reported that an estimated 110 million-plus Americans are obese or overweight with at least one weight-related comorbidity. Excess weight increases the risk of conditions such as type 2 diabetes, high cholesterol, high blood pressure, heart disease, sleep apnea, stroke and osteoarthritis. According to the National Institutes of Health (NIH), losing just 10% of body weight may help obese patients reduce the risk of developing other medical conditions.
