General
Description & Use
Rimonabant (also known as SR141716, Acomplia, Bethin, Monaslim,
Remonabent, Riobant, Riomont, Slimona, Rimoslim, and Zimulti)
is an anorectic anti-obesity drug. It is an inverse agonist for
the cannabinoid receptor CB1. Its main avenue of effect is reduction
in appetite. The uses of RIMOSLIM (Acomplia, Generic Rimonabant)
include: Appetite suppressant, Anti obesity weight loss drug;
significantly reducing human visceral fat (the metabolically active
fat wrapped around the bodys vital organs in the abdomen, Liver.
A single pill has been found to stop both food and cigarette cravings
enough to help people quit smoking and lose weight, and could
also help curb other unhealthy urges. In one study the medicine
helped people who were overweight drop an average of 20 pounds
and in another doubled the chances that smokers would quit. Acomplia
contains the active ingredient Rimonabant. It is a selective CB1
Endocannabinoid Receptor Antagonist. Rimonabant works by blocking
receptors of a substance called cannabinoid 1, which stimulates
hunger and other cravings in the brain and is also present in
fat tissue. Active Ingredient: Rimonabant.
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Acomplia can also prevent the risk of Cardiovascular disease.
Patients with large waist circumference (102 cm in men and 88
cm in women) will mostly benefit from taking the drug. ACOMPLIAŽ
(rimonabant) approved as an adjunct to diet and exercise for the
treatment of obese patients (BMI = 30 kg/m2), or overweight patients
(BMI > 27 kg/m2) with associated risk factors such as type 2 diabetes
or dyslipidemia. Side Effects: Acomplia was said to be well tolerated
in early tests. The only relatively common side effects were mild
GI side effects and dizziness, and these were said to be transient.
Rimonabant
is the first selective CB1 receptor blocker to be approved for
use anywhere in the world. In Europe, it is indicated for use
in conjunction with diet and exercise for patients with a body
mass index greater than 30 kg/m², or patients with a BMI
greater than 27 kg/m² with associated risk factors, such
as type 2 diabetes or dyslipidaemia. In the UK, it has been available
since the end of July 2006. As of 2008, the drug was available
in 56 countries.
Smoking
cessation
Rimonabant may also be found to be effective in assisting some
smokers to quit smoking. Sanofi-Aventis is currently conducting
studies to determine the possible value of rimonabant in smoking-cessation
therapy. The Studies with Rimonabant and Tobacco Use (STRATUS)
Program involves more than 6,000 subjects. STRATUS is designed
to explore two smoking-related therapies: first, to use rimonabant
directly to aid in smoking cessation; second, to help prevent
weight gain in former smokers. Initial results apparently suggest
that rimonabant is effective for both uses. However, the FDA has
explicitly stated to Sanofi-Aventis that without additional studies
rimonabant cannot be approved in the United States for smoking
cessation therapy.
Approval
Despite the FDA issuing an approvable letter in February 2006
for the obesity indication and a non-approvable letter for smoking
cessation, the drug did not enter the market in the United States
in 2006. The French pharmaceutical company Sanofi-Aventis disclosed
that a complete response to the FDA's approvable letter was submitted
in 2006, triggering a Class I (two-month) or Class II (six-month)
review process. In 2007, FDA's Endocrine and Metabolic Drugs Advisory
Committee (EMDAC) concluded that the French manufacturer Sanofi-Aventis
failed to demonstrate the safety of rimonabant and voted against
recommending the anti-obesity treatment for approval. Subsequently,
Sanofi-Aventis announced that it was withdrawing the new drug
application (NDA) for rimonabant and that it would resubmit an
application at some point in the future.
in
June 2006, the European Commission approved the sale of rimonabant
in the then 25-member European Union. Sanofi announced that the
first country in which Acomplia will be sold is the United Kingdom.
Sales began in July 2006. Sanofi also announced that it projects
that the drug will be sold shortly thereafter in Denmark, Ireland,
Germany, Finland and Norway. It is expected in Belgium and Sweden
in 2007. Ordinary obesity will, according to official medical
recommendations, not be enough to acquire the prescription in
Sweden; there are additional requirements concerning abnormal
blood lipid levels.
The
EU's approval was not a blanket approval, nor did it approve Acomplia
for non-obesity related problems such as smoking cessation, although
off-label use of the drug is still possible. The approval is in
combination with diet and exercise for the treatment of obese
patients (BMI greater than or equal to 30), or overweight patients
(BMI greater than 27) with associated risk factors, such as type
2 diabetes or dyslipidaemia.