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Vivus's weight-loss drug Qnexa is heading into an FDA review with the backing of generally positive study data. Will FDA give the thumbs up? Depends on how severe it thinks the side effects are.
Vivus, in anticipation of its June 15 FDA advisory committee meeting, unloaded a bevy of research this week, documenting the benefits of its new anti-obesity drug, Qnexa. The biopharmaceutical firm is hoping that the medication will be a happy medium for patients that don’t lose enough weight on over-the-counter treatments and don’t want to undergo evasive surgery.
Qnexa, a combination of phentermine and topiramate, was found to be effective in suppressing patients’ appetites and keeping their hunger sated.
In order to be considered for approval, Vivus had to prove that the drug could help obese and overweight patients lose 5 percent of their body weight compared to a placebo group. In clinical trials, Qnexa reduced 10 percent of body weight in patients taking a high dosage of the drug, while patients taking lower and medium dosages lost 5 percent and 8 percent, respectively. An increase in adverse reactions was reported in those taking the higher dosage.
This approval should be a slam-dunk for Vivus, if not for the fact that FDA has a hard time getting over the weight-loss drug woes of the recent past. Case in point: Fen-phen-Wyeth’s catastrophic weight-loss drug that was pulled from the market in the mid-’90s after being attributed to heart attacks and death. The drug apparently worked in clinical trials, but the benefits far exceeded the risks. To make matters worse, phentermine is the ‘phen’ in Fen-phen, albeit not the ingredient that caused the severe issues.
The good news is that Qnexa’s adverse reactions appear to be far less serious. According to Vivus, side effects include dry mouth, insomnia, and a “small increase in depression.” However, the company argues that the benefits far outweigh the risks, since obesity can lead to hypertension, diabetes, and a generally terrible quality of life.
In a 300-plus page document to FDA, Vivus noted that nearly 68 percent of adults in the US are obese or overweight. “Recent data suggests that if current increases in obesity rates continue over the next decade, the health consequences of obesity will negate the gains in health benefits achieved through the reduction in smoking rates,” the company stated.
A final FDA decision will be released in October.