FDA denies Weight Loss Combo Drug Contrave And Other Weight Loss Drugs

FOR IMMEDIATE RELEASE
Spring, Texas, United States of America (Free-Press-Release.com) February 5, 2011 -- A pill combining bupropion and naltrexone for
weight loss (Contrave) won't receive the FDA's
approval until its manufacturer, Orexigen, conducts a
new clinical trial evaluating its cardiovascular risks,
the company said.

In an unusual move, the agency went against the
recommendation of its advisory committee on
endocrine and metabolic drugs, which voted 13-7 in
December in favor of approval.

The agency disagreed with the committee majority on
whether the product's acknowledged cardiovascular

risks outweighed its clinical benefit.

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Orexigen had submitted four placebo-controlled,
one-year, phase III clinical trials in support of its
application. The trials included 3,200 obese patients
with at least one comorbid condition, including
diabetes and depression.

In all four trials, patients on the

naltrexone/bupropion combination lost more weight
than those in the placebo group, and more than 30
percent had a weight loss of at least 5 percent of their
body weight, which is one standard by which the FDA
judges efficacy of weight loss drugs.

In a pooled analysis, naltrexone/bupropion patients
had a weight loss average of 4.2 percent more weight
than the placebo group (ranging from 3.3-4.8 percent). That
falls short of the other FDA standard that, after one
year, the difference in mean weight loss between the
active and control groups should be at least 5%.

But patients taking the combination pill -- especially
those whose weight loss was less than 5 percent --
also showed increases in blood pressure. Blood
pressure elevations and cardiovascular events were
recorded as adverse events, but were not prespecified
endpoints.

Orexigen said the FDA's complete response letter
denying the approval stated that, "before your
application can be approved, you must conduct a
randomized, double-blind, placebo-controlled trial
of sufficient size and duration to demonstrate that the
risk of major adverse cardiovascular events in

overweight and obese subjects treated with
naltrexone/bupropion does not adversely affect the
drug's benefit-risk profile."

Bad Year for Diet and Weight Loss Drugs

The FDA's denial was the third for a weight loss
product in the past year. In 2010, the agency also
rejected applications for phentermine/topiramate
(Qnexa) and lorcaserin hydrochloride (Lorqess),
although in those cases the Endocrine and Metabolic
Drugs Advisory Committee had voted against their
approval.

For Contrave, the panel majority indicated that,

although the weight loss benefit appeared smaller
than for the other drugs, its adverse effects were less
significant as well, tipping the balance in the
product's favor.

Both bupropion (Wellbutrin) and naltrexone (Vivitrol)
have been available individually for two decades, but
the idea of combining them for weight loss is new
enough that the Contrave studies have provided most
of the evidence base.

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