«
March 2007
Weight management is not enough for cannabinoid
March 08, 2007
Mar 08, 2007 | The Business Intelligence firm La Merie
S.L. reported today that Sanofi-Aventis’ first-in-class
CB1 antagonist Acomplia (rimonabant) has at least five competitors
in clinical stages up to phase III and many more in earlier
phases of R&D. While Acomplia received EU approval in
June 2006, the FDA requested more time to review the file.
Acomplia is indicated for the treatment of patients with
obesity or overweight plus cardiometabolic risk factors
and achieved EU sales of € 31 mln in its first months
in selected markets. However, some countries such as Germany
consider Acomplia
as a non-reimbursable life-style drug. Sanofi-Aventis is
undertaking a huge clinical program to profile Acomplia
in additional populations such as in type 2 diabetes (1st
line), insulinized patients, dyslipidemia or atherosclerosis.
Another field of potential use of CB1 antagonistlies in
neuroscience, such as addiction and cognitive disorders.
These results and more were found in a search conducted
by La Merie Business Intelligence. The competitor analysis
of CB1 antagonists can be acquired at www.pipelinereview.com,
La Merie’s News Center and Online Store.
Rimonabant has been studied in more than 6,000 patients.
Results of the RIO-LIPIDS study showed that a one-year treatment
of overweight and obese patients with abnormal lipid levels
with once daily rimonabant significantly reduced body weigth
by an average of 6.9 kg in comparison to a loss of 1.5 kg
in the placebo group. More importantly, it improved a range
of cardiometabolic risk factors that may contribute to type
2 diabetes and heart disease. Results of a two-year treatment
with rimonabant in the RIO-North America study evidenced
sustained effects on waist circumference, body weight and
cardiometabolic risk factors. Mechanism-based adverse effects
associated with CB1 receptor antagonists have not been reported.
Results of the SERENADE trial published in December 2006
showed that patients with type 2 diabetes not currently
treated with anti-diabetic medication experienced significant
improvements in glucose control and weight as well as in
HDL cholesterol and triglycerides. Importantly, about 57
% of the improvements in HbA1C were independent of the weight
loss achieved.
The mechanism of action of CB1 antagonists still is not
yet fully understood. Data indicate a loss of appetite as
well as an increase in metabolic rate and a loss of fat
mass. In addition, it has been shown that cannabinoid antagonists
can prevent drug reinstatement with cocaine, alcohol and
nicotine. Sanofi-Aventis had studied rimonabant as an aid
to smoking cessation and submitted an NDA based on studies
for up to one year in over 6,500 smokers. However, the FDA
issued a non-approvable letter for this indication. Studies
with other molecules are ongoing to explore the utility
of CB1 antagonist in the neuroscience field.
Source:- http://www.pipelinereview.com
