University of Liverpool Professor Jason Halford said drug companies are taking a multi-pronged appro...

1. FDA To Review First Of 3 New Weight Loss Drugs
University of Liverpool Professor Jason Halford said drug companies are taking a multi-pronged
approach for you to obesity therapies since science has shown you can easily find multiple mind
signals that drive meals intake.
The diet drug fenfluramine, which ended up being 50 % of the fen-phen combination, ended up
being withdrawn within 1997 following it had been linked along with heart damage. The Actual
drug's combination with phentermine ended up being well-liked however by no means approved
simply by FDA.
None with the 3 medicines represents any breakthrough throughout research. Drugmakers have
made little headway inside comprehending and treating the particular leads to involving overeating.
A Couple Of of the drugs submitted pertaining to approval merely combine various current drugs - 1
using worrying aspect effects. the third, a brand new medication, can be safer yet much less
effective.
Investors clearly favor Vivus in the three-way race. Shares regarding Vivus possess practically
doubled over the past yr to close Friday from $11.52.
"We're making use of combinations regarding outdated drugs using a extremely broad spectrum of
pharmacotherapy, it's quite definitely your shotgun approach," said Halford, any well being
psychologist who has consulted for drug companies upon weight problems treatments.
Qnexa is a combination of 2 older drugs: the amphetamine phentermine and topiramate, an
anticonvulsant drug sold simply by Johnson Johnson as Topamax. According for the company,
phentermine helps suppress appetite, whilst topiramate helps make patients feel more satiated.
The quest for a blockbuster weight reduction drug continues for you to be plagued for decades
simply by safety issues. Your nearly all notable ended up being Wyeth's diet program pill-drug
combination, fen-phen, that has been pulled off the market throughout 1997 because associated with
links in order to heart-valve damage and also lung problems.
The FDA is anticipated to write its review of Vivus Inc.'s pill Qnexa about Monday and will hold a
new public meeting Thursday for you to review the data. Arena Pharmaceuticals Inc.'s lorcaserin is
defined for an FDA panel review in September, although Orexigen Therapeutics Inc.'s Contrave will
probably be the niche of your December panel.
Two years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia because
of to psychiatric facet effects, including depression and also suicidal thoughts.
With U.S. obesity prices nearing 35 % with the adult population, anticipations are substantial for the
1st new prescription drug therapies for you to emerge inside more than the decade. Perhaps a
modestly effective drug offers blockbuster potential.
Decision Resources, a drug industry analysis firm, believes seventy one drugs could eventually earn
approval in order to always be able to find a place in the global weight problems market. The

2. Particular firm expects the actual global marketplace in order to soar through $500 million to $3.4
billion annually through 2018.
"No single agent can be likely to shut down this behavior," said Lowe, whose weblog "In the actual
Pipeline" concentrates on drug development. "But in the huge event you can can always be located
in and hit a pair of or even really these distinct pathways in the same time, maybe then you'll obtain
somewhere."
WASHINGTON -- Dieters, doctors and investors obtain initial extensive take a look at the first of the
trio of recent weight reduction drugs this week. the hope is that the newest drugs may succeed
where many other people get failed: delivering significant weight-loss with out risky facet effects.
While Arena's drug trails its competitors in weight loss, seems like for you to hold the least facet
effects, a significant element in FDA approval.
Still, a history involving diet program drugs is actually littered together with stumbling blocks.
Side effects have got held the little quantity of weight-loss drugs currently about the market through
being blockbuster sellers. Abbott Laboratories' appetite suppressant Meridia had been pulled from
the industry in Europe final November due to be able to information showing increased coronary
heart attack risks. As Well As within May, the particular FDA warned customers the over-the-counter
weight reduction pill alli, that may be marketed for the extended time with a higher dose since the
prescription drug Xenical, could trigger severe liver damage. the drug works by limiting the
particular amount of body fat your body can easily absorb.
"There's zero obvious distinct winner," said Leerink Swann analyst Steve Yoo. "If a person look at
distinct aspects, every drug shines."
Arena Pharmaceuticals shares possess fallen practically 4 % more than days gone by 12 months
about lackluster results for its drug. Orexigen shares have fallen 21 percent over days gone by year,
to close Friday from $4.17, marking the bouncy descent from a June 2007 peak regarding $17.70 a
new share.
Qnexa confirmed the actual very best weight loss leads to clinical trials, with patients losing
between 13 % along with 15 percent of their body weight. but your drug in addition had your highest
price associated with patient dropouts thanks in order to facet effects, that consist of memory along
with concentration problems.
To become considered effective, weight problems drugs ought to decrease total physique excess
weight through a minimal of 5 % right after one year, in accordance with FDA guidance in order to
companies.
Contrave is also a combination pill, mixing an antidepressant with an anti-addiction drug. The
Particular drug has shown weight loss between 5 % as well as ten percent using unwanted effects
for example nausea.
Derek Lowe, any pharmaceutical researcher as well as blogger, says the new combination drugs
beneath review hold guarantee because that they function upon multiple mind chemicals which drive
overeating.

3. The 1 genuinely novel drug below FDA review showed the particular weakest brings about clinical
trials. Arena Pharmaceuticals' lorcaserin can always be a first-of-a-kind drug that will acts about
serotonin receptors. However patients throughout organization trials lost just 5 percent regarding
his or her body weight.