Vivus resubmits NDA for Qnexa

October 17, 2011

Vivus has resubmitted its New Drug Application (NDA) for Qnexa (phentermine/topiramate) to FDA.

Vivus has resubmitted its New Drug Application (NDA) for Qnexa (phentermine/topiramate) to FDA.

The resubmission follows an agreement reached in September 2011 with officials of FDA’s Endocrine and Metabolic Division on a plan that allowed for an early resubmission for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI ≥30 kg/m2), or overweight patients (BMI ≥27 kg/ m2) with weight-related comorbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity).

The proposed labeling for Qnexa includes a contraindication for women of childbearing potential. The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

There are an estimated 80 million adult American men and women of non-childbearing potential, based on the National Health and Nutrition Examination Survey (NHANES) 2008 study, who have a BMI ≥30 (obese) or BMI ≥27 (overweight) with at least 1 weight-related health risk, such as diabetes, hypertension, or dyslipidemia, who are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.

“Currently there are very few treatment options available to healthcare professionals to treat the millions of adults suffering from obesity,” Vivus President Peter Tam told Drug Topics.

Tam noted that obesity is a major driver of increased healthcare spending, costing nearly $200 billion per year and accounting for 9.1% of U.S. healthcare spending, as well as 8.5% and 11.8% of annual spending for Medicare and Medicaid, respectively.

“Treatment for obesity other than surgery is not currently covered by most managed care organizations, and it should be,” Tam said. “Obesity is a serious disease that contributes to many covered conditions, such as diabetes and cardiovascular diseases, among others. Qnexa has been shown to consistently help patients achieve and maintain the 10% weight loss goal recommended by the National Institutes of Health, bringing about sustained improvements in cardiovascular and metabolic risk factors.”

The REMS program included with the resubmission will ensure that healthcare professionals, including pharmacists, are aware of the benefits and potential risks associated with the use of Qnexa, Tam added.