Generic Acomplia

• Acomplia (Rimonabant) is the first in a new class of therapeutic agents called Cannabinoid-1 Receptor Blockers (CB1).
• Acomplia is used in the treatment of obesity and related conditions.

• Acomplia acts by selectively blocking CB1 receptors found in the brain and in peripheral organs important in glucose and lipid (or fat) metabolism, including adipose tissue, the liver, gastrointestinal tract and muscle1.
• Acomplia switches off the same brain circuits that make people hungry when they smoke cannabis.
• CB1 receptor blockade with Acomplia acts to decrease the overactivity of the endocannabinoid system (EC system)2,3. The EC system is a recently characterised physiological system that includes receptors such as the CB1 receptor and it has been shown to play an important role in regulating body weight and in controlling energy balance, as well as glucose and lipid (or fat) metabolism.

• Acomplia is used complementary to diet and exercise to treat obese or overweight patients who suffer from Type 2 diabetes and abnormal levels of fat in the blood.
• Sanofi argues that 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.

• Acomplia has been studied by sanofi-aventis as an aid to smoking cessation based on studies for up to one year in over 6,500 smokers motivated to quit smoking.
• Sanofi-aventis submitted a New Drug Application to the FDA, which in turn issued a non approvable letter for Acomplia for use in smoking cessation. An approvable letter was however issued for Acomplia for use in weight management.

• No. Sanofi is still awaiting U.S. marketing go-ahead which it has said could come by the end of this year.
• U.S. health authorities have asked Sanofi for more information on Acomplia.
• Acomplia received European Union marketing approval in June 2006.
• The first launch will take place in Britain in July and be followed by launches in Denmark, Ireland, Germany, Finland and Norway in the second half of this year, according to Sanofi.

• In clinical studies, Acomplia has been shown to improve a wide array of cardiometabolic risk factors as well as promoting sustained weight loss4,5.
• Approximately half of the observed improvement in HDL-cholesterol, triglycerides and HbA1C (an indicator of blood sugar control) in patients who received Acomplia 20mg was beyond that expected from weight loss alone.

• Side effects in the trial on Acomplia in obesity were vomiting and nausea, forcing about 19 percent of patients to leave the trial versus 13 percent of those who took placebo.