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FDA Accepts NDA for VIVUS’ Qnexa

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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.

     

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I serve the interests of medical technology company decision-makers, venture-capitalists, and others with interests in medtech producing worldwide analyses of medical technology markets for my audience of mostly medical technology companies (but also rapidly growing audience of biotech, VC, and other healthcare decision-makers). I have a small staff and go to my industry insiders (or find new ones as needed) to produce detailed, reality-grounded analyses of current and potential markets and opportunities. I am principally interested in those core clinical applications served by medical devices, which are expanding to include biomaterials, drug-device hybrids and other non-device technologies either competing head-on with devices or being integrated with devices in product development. The effort and pain of making every analysis global in scope is rewarded by my audience's loyalty, since in the vast majority of cases they too have global scope in their businesses. Specialties: Business analysis through syndicated reports, and select custom engagements, on medical technology applications and markets in general/abdominal/thoracic surgery, interventional cardiology, cardiothoracic surgery, patient monitoring/management, wound management, cell therapy, tissue engineering, gene therapy, nanotechnology, and others.
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