FDA Accepts NDA for VIVUS’ Qnexa

VIVUS, Inc., has announced that the FDA has accepted its new drug application for the company’s Qnexa, a phentermine/topiramate combination.  The low-dose, oral, controlled-release drug is designed to reduce appetite and increase satiety.

VIVUS, Inc., has announced that the FDA has accepted its new drug application for the company’s Qnexa, a phentermine/topiramate combination.  The low-dose, oral, controlled-release drug is designed to reduce appetite and increase satiety.  According to the company:

The NDA resubmission seeks approval 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 co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling includes a contraindication for women of childbearing potential. The resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

If all goes well, the FDA could approve Qnexa as early as first quarter 2012.

The opportunity for obesity drugs remains an enormous untapped opportunity.  Even the spate of regulatory challenges to obesity drugs over the past year has not dampened the prospects.  With the number of satiety drugs, malabsorption drugs, appetite suppression drugs and combination drugs that will reach the market in the next few years, we project that the global obesity drug market will hit $3.4 billion by 2019.

Source: MedMarket Diligence, LLC; Report #S835.