Rimonabant information online

 

 

Rimonabant (also known as SR141716, Acomplia,
Riobant, Slimona, Rimoslim, and Zimulti)[1] is an anorectic anti-obesity drug.
It is a CB1 cannabinoid receptor antagonist. Its main avenue of effect is reduction
in appetite.

 

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 wih 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 2007, the drug was available in 38 countries.

Contents

 

* 1 Approval

* 2 Side effects

* 3 Smoking cessation

* 4 RIO program

* 5 Notes

 

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.[citations needed] The French
pharma firm Sanofi-Aventis disclosed that a complete response to the FDA’s approvable
letter was submitted on October 26, 2006, triggering a Class I (two-month) or
Class II (six-month) review process. On June 13, 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.[2] 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.

 

On 21 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[3]
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.[4]

 

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.

 

Side effects

 

Shortly after market introduction, press reports and independent studies suggest
that side effects occur stronger and more commonly than shown by the manufacturer
in their clinical studies. Reports of severe depression are frequent. This is
deemed to result from the drug being active in the central nervous system, an
area of human physiology so complex that drug effects are highly difficult to
determine reliably.[5] The reported development of previously clinically silent
multiple sclerosis in one patient taking Rimonabant suggests that any patients
with an underlying neurological condition should not take Rimonabant, given
the neuroprotective role of the endocannabinoid system in many experimental
paradigms of neurological disease.

 

On 15 June 2007 the BBC News reported [6] that a committee advising the US
FDA has voted not to recommend the drug’s approval because of concerns over
suicidality, depression and other related side effects associated with use of
the drug.

 

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.

 

Rimonabant information online
Rimonabant 2007