Talk about "Drug Money!"
Yes..
there's big money in prescription weight-loss drugs.
Oh... and, it's no longer "Weight-Loss" drugs. Today's new
mantra is "Obesity" drugs.
And here come the next BIG 3. One even
claims to cut weight nearly 15 percent. All are moving closer to
market, but all three have issues which may delay market launch.
Here are the names and sales figures projected
for 2013:
- Arena
Pharmaceuticals Inc: lorcaserin = $418
million
- Vivus Inc:
Qnexa = $357 million
- Orexigen
Therapeutics Inc: Contrave = $325 million
The last block-buster, money-grubbing diet treatment was the cocktail
nicknamed fen-phen -- It included the generic stimulant
phentermine combined with either fenfluramine or dexfenfluramine. The
same drugs were recalled in 1997 after they were linked to heart valve
damage.
Drugmaker Wyeth, set aside more than $21 billion to settle fen-phen
litigation.
Another obesity drug developed by Sanofi-Aventis
SA never reached the U.S. market due to psychiatric side effects,
including suicidal thoughts and depression.
Jeez.... are
you kiddin' me???
Yet the temptation to pursue a
new treatment runs high. And it's no wonder. With nearly 68 percent of
the U.S. population considered overweight, with a third obese,
long-term, investors are betting annual sales of an obesity
drug could top $1 billion.
THE DARK SIDE
Like
fenfluramine, Arena's lorcaserin is designed to block
appetite signals in the brain, but it is much more selective in the
receptors it affects. Clinical studies have found no heart problems
associated with the Arena drug.
One year-long trial
showed weight loss of 5.9 percent, compared with 2.8 percent for
patients taking a placebo. (but who cares if the weight loss is muscle
mass and water?)
Vivus' Qnexa combines phentermine
and generic epilepsy drug topiramate, which Johnson and Johnson
sells under the brand name Topamax. One trial showed that taking
Qnexa led to weight loss of 14.7 percent over a year, compared
with 2.5 percent for placebo patients.
But no one seems to point out whether the weight
loss is muscle mass and water or actual fat-loss.
J&J had
studied Topamax as a weight loss drug, but decided not to pursue it
because of adverse side effects. Among clinical "insiders" the drug
became known as "Tope-A-Dope" because people felt goofy and
forgetful." Vivus says such side effects are moderated by the low
drug doses used in Qnexa, which may also cut the risk of obesity-related
diseases.
The third obesity contender, Orexigen's Contrave,
is a combination of antidepressant Wellbutrin, known generically
as bupropion, and naltrexone, which is used to treat alcoholism
and other addictions. Trials have shown placebo-adjusted weight loss of
about 5 percent.
The company says its sustained-release
formulation limits Contrave's side effects, which are mostly things
like nausea, dry mouth and headache.
All three drugs may be approved by the FDA, but because of Qnexa's
side effects, Orexigen's Contrave and Arena's lorcaserin
will likely be used much more widely, according to Claudia Wiatr, an
analyst at Wolters Kluwer Pharma Solutions.
FDA APPROVAL
Vivus' drug will be reviewed in July by an advisory committee to the
FDA, which is slated to decide on the Qnexa application by Oct.
28, 2010. The deadline for the FDA's review of Arena's lorcaserin
is Oct. 22, 2010.
Just in time for the New
Year's resolution "Weight-Loss" season!
Orexigen
filed its FDA application last month, which would indicate an early 2011
review deadline for Contrave.
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