Touting a Study on trim fast slimming capsule

Vivus Omits FDA Rejection in Press Release Touting a Study on trim fast slimming capsule

Here is a curious oversight. Anxious to see its Qnexa diet pill find its way to medicine cabinets, Vivus (VVUS) yesterday issued a press release touting a study in The Lancet medical journal that the drug demonstrated "significant weight loss and broad improvements in comorbidities." The Lancet, in its own press release, suggested "this promising new treatment has additional metabolic benefits improving blood pressure, lipids, glycaemia, and inflammatory markers."

The upshot is that the study suggests the Qnexa diet pill could help overweight people lose more pounds than those who were given a placebo and, therefore, possibly reduce their reliance on meds for other risk factors, namely diabetes, high blood pressure or cholesterol. Such a finding is potentially noteworthy, of course, and is the sort of conclusion any drugmaker with a diet pill would like to publicize. This is especially true of Vivus, since the FDA rejected Qnexa last fall.

However, Vivus failed to mention one thing. The study, which is called Conquer, was one of the same two clinical trials the FDA trim fast advanced last year before deciding to deny approval for Qnexa, The Los Angeles Times points out. The combined results prompted the FDA Division of Metabolism and Endocrinology Products to conclude the weightloss difference between people given Qnexa and those given a placebo was "of nominal statistical significance" (see page 3).

As the paper notes, the subtle use of language may leave a different impression, especially among those who do not compare findings for the drug, which combines topiramate and phentermine, the surviving half of the infamous fenphen weightloss cocktail. The combined press releases might suggest Qnexa is on the verge of a turnaround.

For those those who may not recall, Qnexa has failed to pass muster with the agency over safety issues. An FDA advisory panel last summer refused to recommend approval over cardiovascular risks and teratogenic concerns. One stipulation before Vivus can win approval involves creating a database that examines the incidence of oral clefts in babies whose moms took topiramate (read here).

UPDATE: We should note that this is not the first time Vivus has practiced what some may call selective disclosure. Last week, the erstwhile drugmaker disclosed new, positive heartrisk data from a longterm Qnexa study in a press release. But as The Street wrote, Vivus omitted negative data from the same study. Interestingly, the press release was issued even as complete data was presented to at the recent American College of Cardiology annual meeting. Perhaps, the Securities and Exchange Commission may want to start reading Vivus press releases.