All about Acomplia (Rimonabant)

The UK National Institute for Health and Clinical Excellence (NICE) has approved the use of anti-obesity drug Acomplia (Rimonabant). The green light was given after the medication received positive appraisal from the institute in March.

Acomplia is recommended as an addition to exercise and proper diet for obese and overweight patients who found two other weight-loss medications Reductil (orlistat) and Xenical (sibutramine) ineffective. Now Acomplia can be prescribed by doctors from the state healthcare system of the UK. However, the drug still has to wait for approval in Germany and the United States. Sanofi-Aventis the manufacturer of Acomplia sais they expect that new clinical trials in Type 2 diabetes patients will influence the approval process. Read the rest of this entry »

The manufacturer of Acomplia (rimonabant) Sanofi-Aventis reported that according to the findings of a recent medical trial the drug significantly improved glucose control in patients diagnosed with type 2 diabetes.

The 11-month trial called ARPEGIO involved 368 patients with type 2 diabetes who had been treated with standard insulin-diet-exercise therapies for an average of six years prior to the study. Presenting the results of the trial at the 68th session of the American Diabetes Association Sanofi-Aventis officials claimed that Acomplia had improved the glucose control three times as compared to insulin treatment and healthy lifestyle alone. The group of patients receiving Acomplia also experienced fewer adverse effects related to the treatment such as compared to the control group (16.8% and 19.3% respectively). Read the rest of this entry »

Sanofi-Aventis said a trial of its Acomplia drug involving patients with type 2 diabetes showed a significant improvement in glucose control compared to insulin.

The company said glucose control was three times more pronounced when rimonabant - the generic name for Acomplia - was used rather than insulin and lifestyle advice alone.

Sanofi-Aventis (nyse: SNY - news - people ) said last year it aims to submit rimonabant for worldwide approval in 2009 as a treatment for type 2 diabetes.

Rimonabant has already been approved by the EU with an indication for treating obesity, and is now on sale in a number of European countries.

But in the US the company expects a four-year delay before gaining approval for the drug, for which it withdrew its new drug application after trials revealed possible risks for patients suffering from depression.

Sanofi-Aventis said in the type 2 diabetes trial, symptoms of anxiety were reported for 14 percent of patients in the rimonabant group, versus 5 percent in the control group, while 14 percent showed symptoms of depression in the rimonabant group, versus 7.5 percent in the control group.

According to the data provided by the Decision Resources Research company, the market of anti-obesity medications and therapies is likely to grow five times by the year 2016.
The company’s analysts anticipate that the market worth approximately $478 million 2 years ago will reach almost $3 billion within the next 8 years in the USA and Western Europe.

The report projects that such an incredible market growth will be mostly driven by the expected launch of a number of therapies such as Lorcaserin manufactured by Arena Pharmaceuticals and a combination of Pramlintide and Leptin delivered by Amylin. However, the report also predicts that the cautious attitude of the FDA towards the newly developed anti-obesity medications can significantly slow down the projected growth rates. The authors of the report base their opinion on the case of Rimonabant (Acomplia) manufactured by Sanofi-Aventis and the safety concerns over similar drugs in the class such as tranabant.

Computed Axial Tomography (Cat) scans of patients taking Acomplia (Rimonabant) have proved that the drug is effective in treating dangerous abdominal obesity which is known to cause diabetes.

An international study of Rimonabant in abdominally obese patients sponsored by Sanofi-Aventis confirmed that the diet drug can significantly reduce visceral fat and fatty liver index. 799 patients participated in the ADAGIO-LIPIDIS clinical trial. Apart form the abdominal obesity they were also diagnosed with low HDL-cholesterol dyslipimidia which can develop in atherosclerosis. The purpose of the trial was to evaluate the effect of Rimonabant on the levels of HDL (high density lipoprotein) cholesterol and TG (triglycerides) plasma in abdominally obese patients when prescribed over 1 year period together with a hypocaloric diet. The secondary objective was to asses the safety and tolerability of the patients to 20 mg of Rimonabant.

According to the leading researcher Dr Després of Université Laval (Quebec), patients receiving Rimonabant (Acomplia) had an average increase in HDL cholesterol of 9.7% while their TG plasma level decreased by 15.5%. It was the first Rimonabant trial to use Cat scanning. The results of cat scans suggest that taking the drug for 1 year results in more than 5.1% loss of subcutaneous fat as well as considerable decrease in the fatty liver index.

Acomplia (Rimonabant)

Manufacturer: Sanofi-Aventis

Acomplia (rimobant) is a weight-loss medicine. It is marketed under the brand names Acomplia in Europe and Zimulti in the USA. There is also a generic version of this drug called Rimonabant. Although Acomplia has been approved for marketing throughout Europe, it is still undergoing the process of approval in other countries. Therefore the best way of buying Acomplia is through online pharmacies.

What is it?

Acomplia belongs to the new class of therapeutic agents known as Cannabinoid-1 (CB1) Receptor Blockers. It is used to treat obesity, overweight and related conditions.

How does it work?

Acomplia selectively blocks CB1 receptors of brain and peripheral organs that account for glucose and fat metabolism. It switches off brain circuits that cause the feeling of hunger. By blocking CB1 receptors Acomplia slows down the activity of endocannabinoid system or EC for short. EC system regulates body weight and controls energy balance.

What is it used for?

Accomplia is used as a supplement to diet and exercise for the patients with obesity and overweight suffering from Type 2 diabetes and excessive level of fat in blood.

The manufacturer also claims that Acomplia can decrease the risk of cardiovascular disease.

Can it help to Quit smoking?

According to researches conducted by Sanofi-Aventis Company Acomplia can be used as an aid to smoking cessation but a relevant approvable letter from the FDA has yet to be issued.

What did clinical trial studies of Acomplia show?

The results of clinical studies proved that Acomplia improves a wide range of cardiometabolic risk factors and promotes sustainable Weight Loss. Nearly half of the improvements that were observed in patients receiving 20mg of Acomplia can’t be accounted for by Weight Loss alone.

What are the side-effects?

19% of patients receiving Acomplia vs 13% of those taking placebo experienced vomiting and nausea and were forced to leave the trial.

Marc Cluzel, Sanofi’s head of research, said in a round of interviews in London that he continues to believe Acomplia can be a winner.

Sanofi-Aventis said on April 3rd it still has high hopes for diet drug rimonabant (Acomplia / Zimulti), even though it was rejected by a U.S. FDA advisory panel last year and recent clinical trial news has been less than wildly encouraging.
Acomplia, which was to have been marketed in the United States as Zimulti, was withdrawn from FDA consideration last June after an expert panel unanimously recommended against approval out of concern over depressive and suicidal side-effects.

Data from a new clinical trial of possible use of Acomplia in slowing progression of coronary artery disease was reported this week along with news that 43.4 percent of patients who got rimonabant in this trial suffered psychiatric side effects such as anxiety and depression.

While the results of the heart trial were ambiguous at best, Cluzel put a positive face on it — and reiterated that Sanofi intends to resubmit rimonabant to the FDA and regulators worldwide in 2009 for approval as a treatment for type 2 diabetes.

He noted that the Acomplia development program — involving clinical trials for a variety of conditions in addition to obesity — is only one-third completed.

“It’s very difficult before 2011 to know exactly what will be the full benefits of the product,” Cluzel told the news agency Reuters.

Another Sanofi executive, Belen Garijo, also expressed confidence that sales of Acomplia — which have been disappointing to date — will grow in Europe and other countries where it is on the market.

“We are very confident that Acomplia will grow in Europe,” Garijo told Reuters, noting that it is being reimbursed by insurance in a growing number of markets.

Source: http://www.acompliareport.com/News/news-040408.htm