Vivus Set to Apply for FDA Approval for Qnexa

By Rachel Stockton rachels at foodconsumer dot org

By the end of the year, Vivus will apply for approval from the FDA to introduce a new diet drug that has impressive potential.  The drug, called Qnexa, has more than met FDA requirements in two late stage clinical trials.

In the first randomized trial, 1267 morbidly obese individuals were divided into a control group given a placebo, while the remaining patients took Qnexa.  The second trial consisted of 2487 overweight and obese individuals with problems typically associated with obesity, such as high blood pressure and diabetes.  At the end of both trial periods, those taking Qnexa lost an average of 9% in body weight, nearly twice the 5% weight loss required by the FDA.

And that's not all.  Vivus reports that those taking the drug reduced blood lipids and blood sugar, potentially mitigating further health decline.

The drug is made up of two medications already approved by the FDA.  One is phentermine, the non-lethal component of the controversial drug Fen-Phen, which was ultimately taken off the market due to reported heart complications.  Phentermine, which is of the amphetamine class, is the most prescribed obesity drug in the nation and is typically given to patients who are manifesting weight related illnesses.

However, phentermine taken alone can have some uncomfortable side effects, such as anxiety, depression, and sleeplessness.

Such complications are diminished in Qnexa by the second drug making up the combo, Topamax, an approved anticonvulsant manufactured by Ortho-McNeil, a division of Johnson & Johnson.  This drug has also been prescribed for migraines and has undergone investigational trials to treat bulimia nervosa, chemical dependence and obsessive compulsive disorder.

In tandem, the two drugs that make up Qnexa have not resulted in depression or suicidal tendencies, according to Vivus.  The drug works by stabilizing two brain mechanisms that are pertinent to successful weight loss:  appetite suppression (phentermine) and satiety (Topamax).  While both drugs given separately generate weight loss, the combination of the two produces more dramatic results.