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Weight-Loss Drug Orlistat Soon may be Sold
Over-the-Counter
No magic bullet weight loss of about 5% comes
with low fat diet
 Jan. 24, 2006 Millions of senior citizens will
join millions of others today in rejoicing at the news that a committee
of the U.S. Food and Drug Administration has recommended approval of a
popular prescription diet pill for over-the-counter distribution. Before
the cheering gets too loud, however, seniors must realize that Orlistat
(tetrahydrolipstatin) the prescription versions is Xenical - is not a
magic bullet and it only works with lifestyle changes. Generally, the
weight loss success has been a reduction of about 5 percent.
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GlaxoSmithKline Consumer Healthcare, the drug
distributor requesting the FDA approval as said they requested
consideration of the OTC use "to promote weight loss in overweight
adults when used along with a reduced calorie and low fat diet."
The company said in their argument that one in
three American adults is engaging in a weight loss attempt.
"However; most do not consult a health care
professional, but instead turn to self-help measures. In addition to
diet and exercise this may include use of one or more of the widely
available herbals and other dietary supplements, many of which have not
been the subject of rigorous clinical study and scientific review," they
said.
"Availability of an approved OTC product for weight
loss would provide an important addition to the self-help measures
available to consumers."
The Nonprescription Drugs Advisory Committee and
the Endocrinologic and Metabolic Drugs Advisory Committee met yesterday
and approved the proposal for over-the-counter (OTC) use of Orlistat (tetrahydrolipstatin)
capsules (60 milligrams (mg)) by a vote of 11 to 2. The FDA still must
make the final approval.
In making their argument, GSK said, " Even a modest
5% weight loss, can have considerable medical benefits in terms of
ameliorating the weight-related medical complications. However, although
most Americans recognize the benefits of losing weight, accomplishing
this goal is extremely difficult."
 The prevalence of obesity and overweight in the
United States has reached epidemic proportions. Greater than 120 million
adults (nearly two-thirds of adults) in the United States are affected
and these numbers are increasing.
Overweight and obesity substantially raise the risk
of morbidity from hypertension, dyslipidemia, type 2 diabetes, coronary
heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea,
respiratory problems, and endometrial, breast, prostate, and colon
cancers, according to the presentation.
Obesity, they say, is linked to very high rates of
chronic illnesses and higher health care costs than is smoking or
drinking.
The total economic cost of obesity in the United
States is over $100 billion per year, which GSK says includes more than
$50 billion in avoidable medical costs.
The company also pointed to studies showing life
expectancy trends during the past thousand years have shown a slow,
steady increase. However, within 50 years, obesity will most likely
shorten the average US life span of 77.6 years by at least two to five
years. This is more than the impact of cancer or heart disease.
The FDAs Working Group on Obesity stated, If it
is not reversed, the gains in life expectancy and quality of life
resulting from modern medicines advances on disease will erode, and
more health-related costs will burden the nations healthcare system.
Orlistat, developed by Hoffmann-La Roche (Roche),
was approved by the FDA in April 1999 as 120 mg capsules (Xenical) for
obesity management and to reduce the risk of weight regain in obese and
overweight patients with risk factors.
Roche initiated a program to switch Orlistat 60 mg
to OTC distribution in 2001. In 2004, GlaxoSmithKline (GSK) licensed the
right to OTC Orlistat and assumed ownership for the OTC development
program.
The proposed dose for the OTC version is 1-2
capsules with each meal containing fat, up to six capsules a day, for up
to six months.
How Orlistat Works
Orlistat is a reversible inhibitor of lipases, key
enzymes needed for the hydrolysis and subsequent absorption of dietary
triglycerides. The drug is minimally absorbed (<2% bioavailable) and has
a non-systemic mode of action. It exerts its therapeutic activity
locally in the lumen of the stomach and small intestine to reduce the
breakdown (and thereby, absorption) of dietary fat.
The read the full pdf document presented by the
company for consideration,
click here.
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