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://mediligence.com/rpt/rpt-s835.htm.