The drug, marketed in Europe as Acomplia, may ultimately be sold in the United States as Zimulti -- but that day appears several years off after an FDA advisory panel voted against sale of rimonabant in summer 2007 out of concern over its depressive side effects.
The Zimulti Acomplia Report, updated daily, will track the continuing efforts of Sanofi to get rimonabant approved for sale in the U.S. The Zimulti Acomplia Report also will provide news and reviews related to rimonabant so those eager to try this new anti-obesity drug will have the latest information on availability, weight-loss results and side-effects.
Rimonabant, discovered and developed by French pharmaceutical company Sanofi-Synthelabo, is a new drug thas has shown great promise in trials for the treatment of obesity and related metabolic risk factors.
Rimonabant is already on the market in Europe, being sold under the trade name Acomplia, and is awaiting approval in the United States.The FDA would not permit rimonabant to be sold as Acomplia in the U.S., and Sanofi is now hoping to market it in the United States as Zimulti.
Rimonabant works by blocking the CB1 receptor, one of two receptors found in a newly described physiological system called the Endocannabinoid System (EC System), believed to play a critical role in the regulation of food intake and energy expenditure.
The receptors are present on the surfaces of many cells throughout the body, including fat cells -- which are involved in lipid and glucose metabolism -- and those in the hypothalamus, the brain region that is thought to determine appetite.
Cannabinoids, chemical compounds
produced by your body, latch on to the CB1 receptors, which are overactive in
overweight and obese individuals, sending out a signal that prompts people to
Researchers wondered whether a drug that halted this action might curb appetite, and in 2001, the first animal study was conducted at the National Institute of Alcohol Abuse and Alcoholism in Bethesda, Md.
In the study, genetically altered
mice that lacked cannabinoid receptors ate less than their litter mates, even
after 18 hours of fasting. When the normal mice were given rimonabant, which
blocked their CB1 receptors, the mice reduced their food intake.
In 2002, Sanofi-Synthelabo began human tests.
Acomplia works by selectively targeting and blocking the CB1 receptors, helping normalize the over-activation of the EC system and making hunger or cigarette pangs more manageable.
Much of the excitement about Acomplia stems from early results suggesting that the blocking of signals that control cravings not only facilitates weight loss, but that it also improves cardiovascular/ metabolic risk factors in overweight/obese patients.
In the RIO-Lipids trial, weight loss was accompanied by a decrease in waist size of 3.4 inches demonstrating a significant reduction in abdominal obesity, an independent marker for heart disease.
Dramatic improvements also were reported in lipid profile with a 23% increase in HDL-cholesterol (good cholesterol) and a 15% decrease in triglycerides.
Improvements in glucose tolerance and insulin levels were also reported. Approximately half of the patients diagnosed at the start of the study with metabolic syndrome, who received the higher 20 mg daily dose of Acomplia, no longer had this condition at the conclusion of the trial.
For those interested in a detailed description of the approved use of the diet drug Acomplia (rimonabant) in Europe, the Summary of Product Characteristics (SPC) approved by the EMEA can be read by clicking here.
While Acomplia has been approved for sale in Europe, uncertainties remain about rimonabant's side effects.
Researcher Luc Van Gaal of the University Hospital in Antwerp, Belgium, said 14.5 percent of patients participating in one of the large clinical trials who were on the 20 mg dose stopped taking Acomplia due to adverse side effects. The main side effect, he said, was nausea, which affected one in eight patients.
An earlier clinical trial also had a drop-out rate due to side effects of about 15 percent.
Probably the most objective and comprehensive evaluation of side effects available at the moment is the one published as part of the approval process by European Medicines Agency (EMEA).
This was its report.
ACOMPLIA 20 mg has been evaluated for safety in approximately 2,500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3,800 patients in other indications.
In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7 % for patients receiving rimonabant. The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg. These were usually mild or moderate in severity and resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups.
The following table shows all treatment-emergent adverse reactions from four placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events greater than or equal to 1 %) or considered clinically relevant (for events fewer than 1 %).Classification of expected frequencies of undesirable effects:
Very common (More than 10 out of 100); Common (More than 1 in 100 but fewer than 10 in 100); Uncommon (More than 1 in 1,000 but fewer than 1 in 100); Rare (More than 1 in 10,000 but fewer than 1 in 1,000); Very rare (Fewer than 1 in 10,000), Not known (cannot be established from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
|Infections and infestations||Upper respiratory tract infection||Gastroenteritis||
Mood alterations with depressive symptoms
|Nervous system disorders||
|Respiratory, thoracic and mediastinal disorders||
|Skin and subcutaneous tissue disorders||
|Musculoskeletal and connective tissue disorders||
|Injury, Poisoning and procedural complications||
In clinical studies for other indications, the following additional adverse reactions were commonly reported:− infections and infestations: sinusitis
− metabolism and nutrition disorders: anorexia, decreased appetite− nervous system disorders: disturbance in attention
− gastrointestinal disorders: stomach discomfort, dry mouth
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