Acomplia rimonabant

rimonabant Company: Sanofi-Aventis Acomplia (rimonabant) is an anti-obesity
drug. It was approved for marketing in the European Union in June 2006. Rimonabant
is not yet approved for use in the United States, where it is known as Zimulti

What is Acomplia rimonabant?

• 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.

How does rimonabant work?

• 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.

What is Acomplia used for?

• 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.

Does rimonabant also aid smoking cessation?

• 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.

Acomplia has just been approved in the European Union. Is Acomplia approved
in the United States?

• 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.

What were the results of rimonabant Clinical trial studies?

• In clinical studies, Acomplia has been shown to improve a wide array of
  cardiometabolic risk factors as well as promoting sustained weight loss^4,5.
• 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 alone⁶.

What are the side-effects of Acomplia rimonabant?

• 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.