Global Healthcare

VIVUS, Inc., Presses the Case for Obesity Drug Qnexa, Market Success

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Qnexa, a drug in development by VIVUS, is one of several promising drugs for the treatment of obesity that received adverse FDA decisions, but which are now receiving additional consideration for potential regulatory approval in exchange for completion of results that demonstrate positive outcomes relative to specific FDA concerns. 

From MedMarket Diligence Report #S835:

Qnexa, a drug in development by VIVUS, is one of several promising drugs for the treatment of obesity that received adverse FDA decisions, but which are now receiving additional consideration for potential regulatory approval in exchange for completion of results that demonstrate positive outcomes relative to specific FDA concerns. 

From MedMarket Diligence Report #S835:

Qnexa is an investigational, once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate. Vivus holds that this combination addresses the two main mechanisms that impact eating behavior: appetite and satiety.

In 2010, the FDA rejected Qnexa on the basis that evidence indicated it could cause birth defects in babies born to women who take the drug.  Responding specifically to these concerns, VIVUS has submitted a new application for Qnexa with a commitment to complete a clinical trial (called the “Fortress” trial) of Qnexa to assess fetal outcomes in offspring of women exposed to topiramate during the first trimester of pregnancy.  The initial results from the Fortress trial are due in December 2011.

Obesity drugs represent an enormous untapped opportunity based on their potential to produce significant weight loss without the need of bariatric surgery.  The realizable market for obesity drugs, encompassing satiety drugs, malabsorption drugs, appetite suppression drugs and combination drugs (like Qnexa) will reach almost $16 billion by 2019, while devices in the management of obesity will at that same time reach only $1.7 billion.

The FDA has recently made overtures in the obesity drug market that reflect an apparent recognition that adverse regulatory decisions in 2010 against Qnexa, Arena’s Lorcaserin and Orexigen’s Contrave may perhaps have overreached.


The MedMarket Diligence, LLC., Report #S835, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019”, is a global analysis of the clinical practice, products, technologies, companies and markets in the field of obesity. The report is described in detail at http://www.mediligence.com/rpt/rpt-s835.htm.

     

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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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