Zimulti
Generic name: rimonabant
Company: Sanofi-Aventis
Sanofi-Aventis has withdrawn rimonabant from the market globally and it is no longer under development.1 In June of 2007, the FDA's Endocrine and Metabolic Drugs Advisory Committee recommended against the approval of rimonabant (known in the United States as Zimulti) due to concerns over dangerous psychological side effects, including suicidality and depression. Subsequently, the FDA did not approve rimonabant, and it has never been marketed in the United States. Acomplia, the brand name of rimonabant in Europe, was officially withdrawn by the European Medicines Agency (EMEA) in January 2009 due to the risks of these side effects. Previously, the EMEA had suspended Acomplia from the UK market in 2008 because the agency felt the benefits did not outweigh the risks.
What is Zimulti?
- Zimulti (rimonabant) was the first in a new class of therapeutic agents called Cannabinoid-1 Receptor Blockers (CB1).
- Zimulti was studied in the treatment of obesity, as an aid for smoking cessation, and related conditions.
How does Zimulti work?
- Zimulti 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 muscle.2
- CB1 receptor blockade with Zimulti acts to decrease the overactivity of the endocannabinoid system (EC system).3,4 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.
- Zimulti switches off the same brain circuits that make people hungry when they smoke cannabis. As a result, people who take Zimulti eat less and lose weight.
What is Zimulti used for?
- Zimulti was studied to be 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 argued that Zimulti could also prevent the risk of cardiovascular disease.
Does Zimulti also aid smoking cessation?
- Zimulti had 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 for Zimulti to the FDA, who in turn issued a non-approvable letter for Zimulti use in smoking cessation, and an approvable letter for use in weight management. However, in June of 2007, the FDA's Endocrine and Metabolic Drugs Advisory Committee recommended against the approval of rimonabant for any indication due to concerns over dangerous psychological side effects, including suicidality and depression. Subsequently, the FDA did not approve rimonabant, and it has never been marketed in the United States.
What were the results of the clinical studies?
- In clinical studies, Zimulti was shown to improve a wide array of cardiometabolic risk factors as well as promote sustained weight loss.5,6
- Approximately half of the observed improvement in HDL-cholesterol, triglycerides and HbA1C (an indicator of blood sugar control) in patients who received Zimulti 20mg was beyond that expected from weight loss alone.7
Zimulti side effects
- Side effects in the trial on Zimulti in obesity were vomiting and nausea, forcing abou...
