After
first being turned down by the Food and Drug Administration,
makers of the investigational weight-loss drug Qnexa have
promising new data to report and will ask less of the FDA this
time around.
Vivus
Inc, of Mountain View, Calif., sought FDA approval last year
to market Qnexa for weight loss in adults. But the request was
denied with the FDA citing a potential side effect in women
who become pregnant while taking the medication. Qnexa is a
combination of two existing drugs — the stimulant
phentermine and the anti-seizure drug topiramate. Topiramate,
however, has been linked to cleft palates.
Now
Vivus is asking for approval of Qnexa with labeling that would
exclude use by women of child-bearing age. If approved, Qnexa
would join Xenical as the only other prescription weight-loss
medication. Several other companies seeking approval of new
weight-loss drugs have also hit a brick wall with FDA in
recent years.
The new
filing on Qnexa before the FDA shows an average weight loss of
14 percent over one year. However, another study, published
online this week in the American Journal of Clinical
Nutrition, is a summary of weight loss over two years of use
and finds an average loss of about 10 percent of initial body
weight. Patients also had improved cardiovascular and
metabolic risk factors, such as lower cholesterol and a lower
risk of diabetes.
The FDA
is expected to reach its decision on Qnexa in the first half
of 2012.