Zimulti Blog - Zimulti Acomplia Rimonabant

Diet drug rimonabant (Acomplia / Zimulti) has been approved by ANVISA, the Brazilian health authority, for sale in Latin America's largest country, drug-maker Sanofi-Aventis announced on April 26th.

Acomplia was approved by Brazil for use "as an adjunct to diet and exercise for the treatment of obese patients (BMI more than 30) or overweight patients (BMI more than 27) with associated risk factors, such as type 2 diabetes or dyslipidemia."

Brazil thus joins two other large countries, Argentina and Mexico, where the diet drug already is on the market.

Meanwhile, Acomplia Report has learned that the Netherlands has become the latest European country to reject insurance reimbursement for patients purchasing Acomplia.

The German state insurance system earlier classified Acomplia a life-style drug and rejected reimbursing patients, and the French government has agreed to provide partial coverage only for obese (not simply overweight) patients who also have inadequately controlled type 2 diabetes.

Source: Acomplia Report

Labels: Acomplia, Weight Loss, Zimulti

Sanofi’s diet drug Rimonabant (Acomplia / Zimulti), which is seeking clearance from the FDA, has got a competitor in “Taranabant”-- official generic name for Merck's MK-0364. The drug is in its phase III trials.

According to reports, Taranabant is Merck's cannabinoid-1 (CB-1) receptor inverse agonist and is as effective for weight loss as Rimonabant, with fewer side effects.

However, Merck has said the pill was well tolerated in extensive phase II trials and that it plans to seek FDA’s nod for Taranabant next year.

Pfizer has not come out with a name for its diet drug, which, as of now is known as CP-945598. It is also a CB-1 receptor antagonist currently in its phase III trials.

Come June and both Merck and Pfizer will be eagerly watching the outcome of the FDA advisory panel meeting on Rimonabant, which is expected to focus mainly on its safety issues.

Obesity generally makes life hell as it is associated with numerous sufferings. Everything in the world is designed for the convenience of a normal non-obese person. An obese feels difficulty in climbing stairs because knee joints are not designed to carry heavy load of the body. Pot-belly doesn’t leave much space between steering and stomach while driving a car because car seats are not designed for an obese. There are numerous such problems which an obese often faces in accomplishment of day to day work.

Moreover, obesity is associated with many fatal diseases like heart attack, prostate cancer and stroke. Regular exercise cannot help in curing obesity when calories burnt in gym are later on substituted by excessive intake of high calorie food. Acomplia is a ray of hope for millions of obese across the globe. This magical pill Acomplia doesn’t work like normal appetite suppressants, those generally have many side effects and compel regular use for rest of life.This medicine inhibits working of CB-1 receptor which is present on the surface of every cell of human body. CB-1 receptors are particularly responsible for the transmission of hunger signal from cell to brain.

Acomplia cures abnormality in this signaling and diet becomes balanced. After using Acomplia you will not feel uncontrolled urge for food even if your favourite dish is placed in front of you. Acomplia also has proven efficacy to suppress tobacco addiction because the same CB-1 receptor is responsible for generating affinity towards tobacco and Acomplia blocks it. It is an oral-prescription drug which must not be taken without doctor’s prescription. Doses of 20mg of Acomplia can produce significant effects and reduce upto 5% of original weight of the body. Exercising cures obesity well when it is accompanied by proper dosages of highly effective Acomplia. Sanofi-Aventis (the manufacturing company) is planning to introduce Acomplia by the name of Zimulti in the US. No matter whatever is the brand name, the basic constituent of Acomplia is Rimonabant, which is primarily an appetite suppressant.

Though this medicine is not a FDA approved drug, but Sanofi-Aventis is in negotiation with governmental agency and expecting approval very soon in the US. Acomplia (Rimonabant) also has some mild side-effects like gastro-intestine disorder, nausea, headache, cramp, etc. If any symptom persist for long doctor must be contacted immediately. Acomplia is prohibited for pregnant women and women who are planning to conceive. The side effects of Acomplia are too benign and short-termed in comparison to dual benefits it produces in the form of anti-obesity and tobacco addiction curing medicine.

Source: http://www.diet-pill-hoodia.us/

Removal of extra body weight from your body can be a quite difficult task. This situation is absolutely true in the present circumstances, where one barely gets enough time to take care of their well-being because of their jam-packed work schedule and busy life works.

Overweight and diseases that are connected with overweight are gulping down millions of people every year all around the globe. Red carpet for obesity is laid down by improper food habits and unbalanced diet. Balanced diet and doing appropriate work out are the basic requirement for anyone to get rid from this epidemic which has caught in major part of USA. Although they sounds good but both are hard to follow as our highly mechanized life style does not permit us to do more physical work.

Moreover, the high calorie junk food is thing for which temptation is irresistible. In such a serious situation, there is a desperate need for a stable and permanent solution which can be helpful without putting any restriction on your food habits and with small amount of work out. Weight loss pills have no doubt made their presence felt in the recent past, because there are many pills which are offering a permanent solution.

Among the enormous list of weight loss diet pills available in the market, zimulti (rimonabant) is also the one which can provide you with an ultimate answer for weight loss. Zimulti diet pill also known as rimonabant is developed by Sanofi-Aventis, a French pharmaceutical firm. Zimulti is an effective oral prescription weight loss medication.

Read the rest of this entry ...

Labels: Acomplia, Zimulti

People who are 100 pounds or more overweight are the fastest-growing group of overweight people in the United States, researchers reported on Monday.

They found the proportion of the severely obese was 50 percent higher in 2005 than it had been in 2000 — a startling rate of growth.

“The proportion of people at the high end of the weight scale continues to increase at a brisk rate despite increased public attention on the risks of obesity and the increased use of drastic weight loss strategies such as bariatric surgery,” said Roland Sturm, an economist at Rand Corporation, a nonprofit research institute.

“The explosion in the use of bariatric (weight-loss) surgery has made no noticeable dent in the trend of morbid obesity,” Sturm added in a statement.

The researchers found that based on self-reported height and weight, which tends to underestimate the weight part, 3 percent of Americans are already severely obese — defined as having a body mass index of 40 or higher.

Body mass index is calculated by dividing weight in kilograms by the square of a person’s height in meters.

The researchers, whose report will be published later this year in the Journal of Public Health, found that the proportion of Americans with a BMI of 30 or more increased by 24 percent between 2000 and 2005.

Source: Reuters

Labels: Acomplia, Weight Loss, Zimulti

Weight loss concern has a caught up fire with the young and the old in the recent times. But how many of actually adopt effectual methods to attain weight loss? Practices like strenuous exercises and starving diets do help some, but that may not work for all.

In view of the weight loss craze, many weight loss medications are now marketed. Amongst these Acomplia (Zimulti in the USA) has emerged as a promising weight loss drug, with its long trail of success stories. Nigel Wescott, spokesperson of Acomplia Buy comments, “Despite the tough competition in the weight loss market, Acomplia has proven to be a medication which has effectually helped many obese and overweight individuals shed weight”.

Mr. Wescott says, “Many pharmaceuticals have preparing to launch competitors of Acomplia soon, but their fate is yet uncertain”. Pfizer and Merck, the other well-known drug makers are preparing to give a tough competition to the Sanofi-Aventis’s Acomplia. Taranabant and CP-945598 are weight loss medications which work on the CB-1 receptors, regulating appetite of the body.

Acomplia Buy is a dependable multi-lingual informative website. Information on weight loss medications such as Acomplia, Xenical and Reductil are made available at Acomplia Buy. Useful information such as Acomplia approval FDA, Acomplia Sanofi- Aventis, Rimonabant RIO, Acomplia pill benefits, Acomplia side effects are also made accessible at Acomplia Buy, which is beneficial to widen your range of understanding. Latest articles and latest news on weight loss medications are some of the other useful information made accessible at Acomplia Buy.

Source: AcompliaBuy.com

This cannibinoid receptor antagonist, which is being reviewed as a weight loss drug (you guessed it... it blocks the munchies, even if you are not smoking pot), was to have a final decision on approval status on April 26.

The review period has been extended to July 27. (I reported in November's update that this drug was approved in Mexico.) The latest proposed brand name is Zimulti. The hearing for this drug will be held on June 13, 2007, before the Metabolic & Endocrinologic Drugs Advisory Committee. When the background resource documents are ready, they will be found here.

Source: Shrink Rap

Labels: Acomplia, Zimulti

US regulatory authorities announced that an independent Food and Drug Administration (FDA) advisory committee will hear testimony in June regarding whether the controversial cannabinoid receptor antagonist SR 141716A/Rimonabant (brand name: Zimulti in the USA) is safe for human consumption.

The agency had previously announced that it would decide by April 26, 2007, whether to grant US market approval for Rimonabant as a weight-loss drug.

Neither the FDA nor the drug's manufacturer, Sanofi-Aventis Pharmaceuticals, gave a reason for the postponement.

Under the FDA's revised timeline, the agency's Endocrinologic and Metabolic Drugs Advisory Committee will hear testimony regarding the drug's safety and efficacy on June 13, 2007. The FDA has previously denied Sanofi-Aventis Pharmaceuticals permission to market the drug in the US.

Rimonabant, marketed under the trade name Acomplia, recently received regulatory approval for sale in Europe as a prescription dietary aid. It is the first cannabinoid antagonist ever to be approved for human consumption.

Rimonabant blocks the natural binding of endogenous cannabinoids (as well as exogenous cannabinoids such as delta-9-THC, the psychoactive component of marijuana) to the neuronal CB1 receptors, causing users to lose their appetites. However, because the endocannabinoid receptor system is intricately involved in the regulation of a broad range of primary biological functions *-- including appetite, body temperature, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination --* some experts are concerned that the long-term use of Rimonabant or similar drugs may eventually contribute to a host of significant adverse health effects.

In preclinical trials, newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack the CB1 receptor also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity, and increased mortality compared to healthy controls.

At least one published case study reports that daily use of the drug may have triggered neurological symptoms of multiple sclerosis in a volunteer with no known history of the disease. Mental health side effects, such as depression, are also commonly reported among volunteers administered Rimonabant.

In human trials, daily administration of Rimonabant is associated with lower blood sugar levels and weight loss compared to placebo. Sanofi is seeking to market the drug in the US under the trade name Zimulti.

Source: http://www.thc-detox.com/passtest/post_1176019976.html

The wonder drug Acomplia has been developed by Sanofi, the highly awaited weight loss miracle pill has been very effectual in the treatment of obesity. Not only this, the drug is a relief for millions who were seeking an aid for smoking cessation. The drug was launched in the UK (June 21st, 2006), and some other countries, and will be soon available in the US under the name Zimulti. Whatever the trade name, the drug has already created raves in the diet pill market for its dual benefits and its safety.

This oral anti-obesity pill works on the CB- 1 receptors which are present throughout the body. Acomplia helps in blocking out these receptors which in turn works on reducing intake of food in an individual and curbs their appetite. Weight loss starts taking place as the food intake of an individual is decreased. Acomplia acts on the peripheral organs which play a very important part in lipid and glucose metabolism, including the liver, adipose tissue muscles, and the gastrointestinal tract. Acomplia/Zimulti considerably reduces the appetite of an individual, in turn reducing calorie consumption from reduced food intake.

With this oral pill, the activity of the endocannabinoid system is balanced, which plays a vital role in balancing energy and regulating body weight. Cannabinoids, a chemical compound produced by ones own body start latching on to the CB 1 receptors, which are overly active in obese and over-weight individuals, which send out signals making people eat more than required.

The EC system gets normalized which makes it much easier to manage the urge to smoke and over-consume food. Acomplia also helps in improving cardiovascular/metabolic factors in obese individuals.

Usage Directions for Acomplia:

Consulting your health care professional should be given primary importance, your doctor has to inform you if the medicine is suitable for you nor not. Acomplia is usually taken before breakfast with a full glass of water.

Acomplia banishes the urge to smoke:

Rimonabant (found in Acomplia/Zimulti) is a vital ingredient which has been quite effective in aiding smokers to quit. Acomplia helps in curbing the urge to smoke, tamming the addiction and 'urge' for the chemical nicotine, which is a very addictive and harmful substance.

Side Effects:

Side effects of Acomplia/Zimulti are minor to moderate, they included:

* Depression
* Dizziness
* Irritability
* Nausea
* Restlessness
* Anxiety

Precautions to be kept in mind:

Thinking that the drug will be more effective if taken in larger than professionally prescribed amounts is a major misconception, which can lead to harmful side effects and health complaints.

Remember:

Acomplia is prescribed only for a short term duration program for effective weight loss.

Source: Slim Talk

Labels: Acomplia, Zimulti

Jeanne Whalen, Wall Street Journal, Mar. 29, 2007 12:33 PM

When Sanofi-Aventis SA reported data on a new obesity pill at a medical conference in March 2004, it generated instant buzz. Hundreds of newspaper and television reports around the world the next day referred to the drug, Acomplia, as a "super pill" and a "miracle drug." With a new approach to obesity, Acomplia promised not only to help people shed pounds but also to raise good cholesterol and cut diabetes risk. It even showed signs of working as an antismoking aid." That is amazing. People are going to want this drug today, I'm sure, effused an anchor on ABC's "Good Morning America."

Three years later, Acomplia is looking less like a miracle. The drug still hasn't hit the market in the U.S. The Food and Drug Administration has asked for more data and repeatedly put off approval for the drug as an obesity treatment, while rejecting it for smoking cessation. Side effects associated with Acomplia - including depression and anxiety - are likely giving the FDA particular cause for concern, analysts and doctors say. Sanofi announced this week that the FDA has scheduled a meeting of its outside advisers on June 13 to review Acomplia's safety and efficacy.

That could be a precursor to a final decision. Acomplia faces trouble in Europe, too. European regulators approved it for sale last summer, but Germany's state-financed health-care system thinks the drug has few real medical benefits and is refusing to pay for it. Other countries, including France, are covering the drug only for limited groups such as people with diabetes. Success with Acomplia is important for Paris-based Sanofi, whose 2006 sales of about $38 billion make it the world's third-largest drug maker, behind Pfizer Inc. and GlaxoSmithKline PLC. Several of Sanofi's biggest drugs are facing future generic competition, including anticlotting agent Plavix, which Sanofi jointly sells with Bristol-Myers Squibb Co. Recently there has been talk that Sanofi, which completed a hostile takeover of French-German drug maker Aventis in 2004, might be interested in acquiring Bristol-Myers. The companies declined to comment.

The Acomplia troubles show the challenge companies face in pitching potential hit drugs, especially in markets like obesity where public enthusiasm is apt to jump out ahead of the scientific data and regulators' review. Sanofi initially did little to hold back the hype and even contributed to it by distributing a news release at the March 2004 meeting quoting doctors speaking positively about Acomplia. It also said in February of that year that Acomplia "could become a very large blockbuster."Later Sanofi clamped down on its publicity, and investors complained the company wasn't offering enough information about the repeated delays at the FDA. Sanofi's stock price has dropped 13 percent since February 2006, when the FDA first said it needed more time to review the drug.

In the back of everyone's mind are the diet drugs Redux and Pondimin, part of the combination known as fen-phen. After creating a public sensation, the drugs were linked to heart-valve damage and removed from the market in 1997, triggering lawsuits that have cost drug maker Wyeth more than $21 billion in legal fees, judgments and settlements. If Acomplia is approved for sale in the U.S., some analysts believe it could still reach sales of more than $1 billion a year. Competitors haven't given up on the category: Pfizer, Merck & Co. and Bristol-Myers are studying drugs that work similarly to Sanofi's. Acomplia, known by the generic name rimonabant, attacks obesity in a new way, by blocking receptors in the brain and in fat cells that help regulate appetite and metabolism. Cannabis, the active ingredient in marijuana, acts on the same receptors, which is believed to explain why marijuana users often get hungry. Sanofi at first saw Acomplia as a weight-loss tool.

But as Sanofi's researchers tested the drug they saw evidence of wider benefits: better blood-sugar and HDL cholesterol levels, shrinking waistlines and less of the harmful fats known as triglycerides in the blood. For a time, Sanofi also tested Acomplia as an aid to help people quit smoking. Part of Sanofi's problem is that it has struggled to define what Acomplia is. The company initially viewed the drug as a weight-loss aid, and then shifted to saying it treated risk factors for heart disease and diabetes.

Gerard Le Fur, who was Sanofi's head of research and development for more than a decade before becoming chief executive in January, now says, "If we were to start again, we would say it's an antidiabetic agent" that induces weight loss. Sanofi began reporting results of its Acomplia trials at the American College of Cardiology conference in New Orleans in March 2004. "It's mind-boggling how this one receptor seems to be tied into all of these risk factors for cardiovascular disease," Christopher Cannon, a cardiologist at Harvard Medical School and Brigham and Women's Hospital, Boston, said at the time. Although the company was careful not to call the drug a miracle pill, media reaction was gushing.

"One Pill a Day Could Keep Food and Nicotine Cravings Away," USA Today reported. That month, an online publisher of consumer medical news, Medical Week News Inc., set up a Web site called Acomplia Report. Soon it had about 6,000 visitors a day, says Milton Benjamin, editor and publisher of Medical Week News. He says Sanofi at first cooperated with the site, providing it interviews with company officials and keeping it posted on clinical-trial news. The site's daily traffic rose to 70,000 in November 2004 when Sanofi announced results of a two-year trial in 3,045 overweight and obese patients.

The Sanofi-funded trial, later published in the Journal of the American Medical Association, showed that those who stuck to a daily 20-milligram dose of Acomplia lost an average of more than 17 pounds in the first year, and maintained their new weight for an additional year. Those who lost the weight and then switched to a dummy pill gained nearly all of it back during the second year.But there was a warning sign too: Patients on the 20-milligram dose had a 6.2 percent rate of psychiatric disorders such as depression, compared with 2.3 percent of those taking a placebo.When Sanofi submitted the drug to the FDA and to the European Medicines Agency for review in the second quarter of 2005, the FDA made clear it was perturbed by all the Acomplia chatter, says Dr. Le Fur. "We were told by the FDA not to talk about" Acomplia, he says. "The FDA believed that we put pressure on them through you, the journalists, and the financial analysts, and that is not true."In the wake of safety scandals involving fen-phen and Merck's painkiller Vioxx, the FDA and other regulators are particularly sensitive about approving medications that could be used over long periods for chronic conditions, Dr. Le Fur says. Sanofi took some steps to turn down the volume on Acomplia.

In April 2005, a trademark lawyer for Sanofi emailed Mr. Benjamin of the Acomplia Report warning of legal action unless he transferred the domain name AcompliaReport.com to Sanofi within 10 days. He refused. After a skirmish, he got to keep the name in exchange for publishing a disclaimer that the site was not associated with Sanofi. A Sanofi spokesman says the case was a routine trademark defense that had nothing to do with the site's content. On Jan. 30, 2006, Hanspeter Spek, Sanofi's head of pharmaceutical operations, told financial analysts during a conference call that the company was "very, very confident" it would receive FDA approval and begin selling Acomplia in the second quarter of 2006.

Preparing for a launch, the company sent a 500-person sales force to visit insurers and other U.S. health-care payers. Less than three weeks later, on Friday, Feb. 17, Sanofi issued a terse release saying the FDA had rejected Acomplia as a smoking-cessation treatment, and delayed approval for obesity, requesting more information from the company. Over the weekend, Sanofi's investor-relations department took calls from research analysts. Sanofi officials told those callers that the company expected the drug to be approved "in months, not years," according to several analysts. Some of them reported that intelligence to clients in research notes Monday morning.

The prediction turned out to be wrong, as did a subsequent prediction that the FDA would act by the end of 2006. Sanofi now declines to offer a forecast. The next deadline for the FDA to deliver a yes, a no or another official "maybe" comes at the end of July, 2007. Amit Roy, a pharmaceutical analyst with Citigroup in London, says Sanofi's guidance on Acomplia approval in the U.S. has been "misleading in a sense." There have been "very many delays and very little information," he says. A Sanofi spokesman says the company gave all its guidance in good faith. Dr. Roy now thinks global sales of Acomplia will reach only about $1.3 billion in 2010, down from his previous forecast of more than $2 billion. While the FDA and Sanofi decline to discuss the reasons for the delay, outside specialists believe the sticking point likely has to do with the depression and anxiety side effects.

That's especially an issue for a drug that some patients who are desperate to lose weight may seek out aggressively. "If there are potential adverse psychiatric effects and people are going to be able to buy this over the Web, then it could potentially become unsafe," says Barbara Kahn, chief of endocrinology, diabetes and metabolism at Beth Israel Deaconess Medical Center in Boston. A few months after Acomplia was introduced in the United Kingdom, Frederick West, a 64-year-old with diabetes in Hertfordshire, England, began taking the drug. He lost about 15 pounds in the first few months, but after about four months he started experiencing mood swings including periods of aggression. Mr. West works as a gamekeeper on a large English estate, where he is sometimes required to carry a gun. "I'm normally a very cool person," he says. "I was not behaving in my normal fashion." Mr. West says he decided to stop taking the drug in December and soon returned to normal. He has regained about six pounds since then. European regulators have cautioned that Acomplia shouldn't be used in patients with "uncontrolled serious psychiatric illness such as major depression." However, they have approved the drug for overweight people with diabetes or abnormal levels of fat in their blood, as well as for any person with a body-mass index of greater than 30.

A 5-foot-8 person would have to weigh about 200 pounds to reach that level. Sanofi's Dr. Le Fur says the psychiatric side effects were "mild and moderate" and occurred in a "rather low" percentage of patients in the clinical trials. He also says that the depression and anxiety tended to ease with time.Acomplia is now available in most European countries. Sanofi says sales in 2006 after the mid-year launch were about $41 million, a figure it calls promising. But Sanofi faces a problem getting cash-strapped European health systems to pay for Acomplia. In a major setback, Germany's health ministry in January decided that Acomplia was a "lifestyle" weight-loss drug and refused to pay for it. Sanofi says it plans to challenge the decision in German court. France decided this month to cover Acomplia only for obese people with Type 2 diabetes who have found certain generic diabetes medications ineffective.

Others will have to pay the full 2.60 euros-per-pill cost out of pocket. Sweden has opted to cover Acomplia only for patients with a body-mass index over 35, or for diabetics and certain others with a BMI over 28. To bolster its argument that Acomplia is worth paying for, Sanofi is spending millions on eight additional clinical studies to test whether Acomplia helps lower a person's risk of developing diabetes or having a heart attack or stroke. The largest of these trials involves 17,000 patients and will last five years. Some Web sites have cropped up offering to sell the drug to Americans.

The sites typically arrange for an American to receive a prescription from a doctor in a country such as Britain where the drug is marketed, after which a pharmacy in that country can mail the pills. Although importing most prescription drugs is illegal under U.S. law, the FDA and customs officials mostly ignore small mail orders. In a discussion forum on AcompliaReport.com, readers swap stories about their experiences taking Acomplia. Some describe side effects like an anxious feeling at night. Others have none. "Just a lovely and welcome disinterest in food ... I get hungry around mealtimes and I eat a little and that's it," one reported. Many American insurers refuse to pay for the two main obesity drugs on the U.S. market, Meridia from Abbott Laboratories and Xenical from Roche Holding AG and GlaxoSmithKline, which is now also sold over the counter under the name Alli by Glaxo.

"We understand and we accept that a slimming agent shouldn't be financed by" health insurers, says Sanofi's Mr. Spek. "We have a strong, even vital interest to show that our patients are not those that take the product in order to fit into their bikini."

---Anna Wilde Mathews contributed to this article.

Labels: Acomplia, Zimulti

It's now official. If diet drug Acomplia (rimonabant) is ultimately approved for sale in the United States, the prescription diet pill will go on the U.S. market not as Acomplia but as Zimulti.

Sanofi-Aventis, developer of rimonabant which is now sold in a number of European countries, Argentina and Mexico as Acomplia, has long been coy about what name it intends to use if the FDA approves the diet drug for U.S. sale.

But the pros-and-cons of rimonabant are cheduled to be aired by an FDA advisory panel on June 13th, and the official notice of the hearing published in the Federal Register says the panel will discuss "the efficacy and safety of new drug application (NDA) 21-888, proposed tradename Zimulti (rimonabant)."

The meeting notice published by the FDA Endocrinologic and Metabolic Drugs Advisory Committee also is interesting in that would appear to dash suggestions made by some of Sanofi's favorite financial analysts that the FDA may now approve Acomplia/Zimulti for treatment of type 2 diabetes.

The published notice says the FDA panel will consider rimonabant "as an adjunct to diet and exercise for obesity management in patients with a body mass index equal to or greater than 30, or a body mass index equal to or greater than 27 if accompanied by at least one cardiovascular risk factor."

This not only does not sound like treatment of diabetes, but it also does not sound like an indication for treatment of "metabolic syndrome," which is a package of cardiometabolic risk factors.

If "obesity management" indeed does become the FDA-approved indication, the question of whether U.S. insurers will agree to pay for the diet drug would appear to be very much up in the air.

In Europe, the German state insurance system has classified Acomplia a life-style drug and has rejected reimbursing patients, and the French government has agreed to provide partial coverage only for obese (not simply overweight) patients who also have inadequately controlled type 2 diabetes.

Labels: Acomplia, Zimulti

Sanofi-Synthelabo, a French Pharmaceutical Company created Rimonabant (Acomplia and possibly Zimulti) which is a new drug treatment for obesity and possibly other ailments.

This diet pill was officially approved in Britain on June 28th 2006, which could lead the way to having the FDA approve it in the United States by mid summer, 2007.

But no guarantees, The FDA has strick policies regarding new medications on the market. Acomplia (Rimonabant or Zimulti) diet pills offer hope for obese individuals, especially where other treatments had little affect or the side effects where too much to handle. This medication (as any) obviously does not come without some potential side effects.

Rimonabant works differently than other weight-loss pills, and has other potential benefits. Studies also show that it increases levels of HDL (good cholesterol) while at the same time reducing LDL (bad cholesterol). It could also possibly be used for smoking cessation, although not officially approved for that purpose (yet). Basically, Rimonabant suppresses ones appetite.

It works by blocking a cellular receptor in the endocannabinoid system of the brain, believed to influence the regulation of body weight, glucose, and fat metabolism. In doing so it is believed that this regulation then reduces the craving to eat more.

Clinical Studies have shown that 33% of people taking Rimonabant lost 10% of body weight and kept their weight down for two years which is extremely newsworthy as no other diet drug has accomplished this for so long a period.

It also holds huge potential for the people wanting to kick the smoking habit and 'may' help curb other substance addictions such as cocaine, marijuana, and alcohol.

Source: www.rimonabant-health.com

Labels: Acomplia, Weight Loss, Zimulti

Rockville, MD: US regulatory authorities announced that an independent Food and Drug Administration (FDA) advisory committee will hear testimony in June regarding whether the controversial cannabinoid receptor antagonist SR 141716A/Rimonabant is safe for human consumption. The agency had previously announced that it would decide by April 26, 2007, whether to grant US market approval for Rimonabant as a weight-loss drug.

Neither the FDA nor the drug’s manufacturer, Sanofi-Aventis Pharmaceuticals, gave a reason for the postponement.

Under the FDA’s revised timeline, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee will hear testimony regarding the drug’s safety and efficacy on June 13, 2007. The FDA has previously denied Sanofi-Aventis Pharmaceuticals permission to market the drug in the US.

Rimonabant, marketed under the trade name Acomplia, recently received regulatory approval for sale in Europe as a prescription dietary aid. It is the first cannabinoid antagonist ever to be approved for human consumption.

Rimonabant blocks the natural binding of endogenous cannabinoids (as well as exogenous cannabinoids such as delta-9-THC, the psychoactive component of marijuana) to the neuronal CB1 receptors, causing users to lose their appetites. However, because the endocannabinoid receptor system is intricately involved in the regulation of a broad range of primary biological functions ­– including appetite, body temperature, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination –­ some experts are concerned that the long-term use of Rimonabant or similar drugs may eventually contribute to a host of significant adverse health effects.

In preclinical trials, newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack the CB1 receptor also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity, and increased mortality compared to healthy controls.

At least one published case study reports that daily use of the drug may have triggered neurological symptoms of multiple sclerosis in a volunteer with no known history of the disease.

Mental health side effects, such as depression, are also commonly reported among volunteers administered Rimonabant.

In human trials, daily administration of Rimonabant is associated with lower blood sugar levels and weight loss compared to placebo. Sanofi is seeking to market the drug in the US under the trade name Zimulti.

For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500.

Labels: Acomplia, Zimulti

While FDA held up Sanofi’s diet drug Rimonabant(Acomplia/Zimulti),the Merck’s MK-0364(Taranbant) is currently in phase-3 which is as effective for weight loss as rimonabant having some side effects.

The interim results of phase-3 trial of Taranabant have not been reported by the Merck.These results could be different from the anecdotal report. In the trial it was found that the weight loss pill was well tolerated in extensive phase-2.The Merck is looking forward FDA approval for it next year.

Pfizer, which also contains CB-1 receptor antagonist in phase-3 trials has not moved forward with a name which is known as CP-945598.

In June, 2007 there will be a meeting of FDA advisory panel on rimonabant about the safety issues of drugs which affect receptors in the brain.

Merck and Pfizer are waiting for the meeting.

Diet drug rimonabant (Acomplia / Zimulti) was approved for sale on April 3rd by Switzerland for treatment of obese or overweight patients with at least one type of associated cardiovascular risk.

The approval by Switzerland, which is not a member of the European Union, is similar to the EU marketing approval last June, where the drug was cleared for use in combination with diet and exercise for overweight and obese patients with linked health risks such as type 2 diabetes.

Sanofi-Aventis said regulator Swissmedic authorized the use of the drug for "for obese patients (BMI greater than 30) or for overweight patients (BMI over 27) with at least one associated cardiovascular risk factor, after insufficient weight reduction following physical activity or alimentary adaptation."

Switzerland is a relatively small market, and the news of Acomplia's approval hardly offsets recent disappointing announcements on reimbursement by state social security systems in the large EU countries of France and Germany.

The highly anticipated obesity drug also remains stalled in the key United States market , where it now is scheduled to be reviewed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee at a meeting scheduled for June 13th.

Source: Acomplia Report

Labels: Acomplia, Weight Loss, Zimulti

Diet pill Acomplia (rimonabant), which hasn't had much good news lately, has been anointed by a leading research firm as the drug that will be the "clinical gold standard for treating obesity" in 2010.

Even though Acomplia / Zimulti remains stalled at the FDA, and in the next few years may face stiff competition from several drugs already in or moving into phase III trials, Decision Resources, Inc., in a report issued March 19th, has proclaimed it the diet pill most likely to become the new Number 1.

DRI analysts predicted that rimonabant's side effects of anxiety and depression in some patients "will not stop Acomplia's rise to the top," with it taking over from Xenical (orlistat) as the top selling prescription diet drug.

Decision Resources said it based its findings on a survey of more than 3,000 endocrinologists with large practices as well as on its own analysis and comparisons of the key clinical attributes of current and emerging obesity therapies.

"Besides greater weight reduction and additional cardiovascular benefits, Acomplia promotes a longer period of weight maintenance and greater waist circumference reduction," said Decision Resources analyst Nancy Li.

"Although Acomplia is contraindicated in patients with depression and may cause side effects of anxiety and depression in certain subpopulations, its lack of upsetting GI side effects is a welcome difference for patients who have tried Xenical," Li added. "In addition, Acomplia is dosed more conveniently."

Interestingly, DRI's analysts appeared to focus primarily on two lesser known drugs -- Arena Pharmaceutical's Lorcaserin (APD356) and Alizyme's Cetilistat (ATL-962)-- as potential significant competitors to Acomplia in the immediate years ahead.

Arena has a two-year Phase 3 trial of lorcaserin underway that is expected to enroll 3,000 overweight and obese patients at about 100 centers in the United States. Lorcaserin stimulates the 5-HT2C serotonin receptor, located in the hypothalamus, which helps regulate fullness and influences the metabolic rate.

Alizyme is preparing to launch phase III trials for Cetilistat after completing an extensive Phase I and Phase II clinical development program. Cetilistat is a gastrointestinal lipase inhibitor which blocks fat digestion and thus absorption, but with far fewer gastrointestinal adverse events than Xenical.

In the report, DRI forecast that Lorcaserin would launch in 2009 and have peak year sales of only $250 to $500 million. It forecast that Cetilistat would launch in 2010 and have peak year sales that would only be half of Lorcaserin.

Curiously, the report gave no consideration to the possible competition posed for Acomplia by two other CB-1 receptor antagonists that Merck and Pfizer both have in Phase III trials. If either the weight-loss performance or side-effect profile of one of these drugs is better than rimonabant, it could have a major impact on Acomplia sales.

To buy the Decision Resources report, click here.

Labels: Acomplia, Weight Loss, Zimulti

Rimonabant, discovered and developed by French pharmaceutical company Sanofi-Aventis, is a new drug that 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. It appears that the FDA will not permit rimonabant to be sold as Acomplia in the U.S., and Sanofi is believed preparing 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).

The Endocannabinoid System is 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 eat more. 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-Aventis began human tests.

Zimulti 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 Zimulti 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 Zimulti, 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 Zimulti/Acomplia (rimonabant) in Europe, the Summary of Product Characteristics (SPC) approved by the EMEA can be read by clicking here.

Labels: Acomplia, Weight Loss, Zimulti