For the millions of American's wondering when highly anticipated diet pill Acomplia (rimonabant ) may be obtainable in the United States, the next opportunity for developer Sanofi-Aventis to update the world on where things really stand with the U.S. Food and Drug Administration comes on August 2nd.

That's the date Sanofi's top executives plan to meet with financial analysts to report on the company's first half 2006 earnings, after which the analysts get a chance to ask questions.

It's been more than five months now since Sanofi-Aventis dribbled out the news that the FDA had decided not to allow Acomplia to be sold in the United States until certain unspecified conditions are met.

At past sessions of this kind, Sanofi has brushed aside all questions about why the FDA was delaying action on Acomplia, telling analysts only that it was responding to the FDA, and expected to have Acomplia approved and on sale in the United States as a weight-loss medication in the second half of this year.

The likelihood of that now happening, in the view of most observers, is very close to zero. So given Sanofi's financial stakes in getting what they foresee as a $5 billion drug into the U.S. market, we would hope analysts might be a bit more aggressive in seeking to determine when the Acomplia revenue stream (and the availability of the drug to U.S. patients) might start.

Sample question for analysts: What issues are holding up approval at the FDA?

While Acomplia has been on the market now in the U.K. for just over a month, and is expected to be launched in a half-dozen other European markets in the months ahead, the revenue the drug will produce for Sanofi during the balance of this year is trivial compared to what is at stake in the United States.

Sample follow-up question for analysts: Have you had have any indication when Acomplia will be considered by an FDA advisory committee?

Source:Acomplia Report 

Dec. 16, 2004 -- It's a struggle that's familiar to many people.

"I have had a weight problem my entire life and have yet to find anything besides good old-fashioned exercise [that works] and most of the time that doesn't do much either."

"I am at least 50 pounds overweight. No matter how much I try it is impossible to lose weight."

"I am interested in losing 30 pounds and have been trying so hard, but nothing seems to keep it off."

These and other personal stories filled WebMD's email boxes in response to a recent news article, titled "Experimental Diet Drug Has Staying Power," about a new weight loss drug called rimonabant. The article generated far more responses than any other WebMD news report in recent memory, including those about weight loss and about other promising drugs.

The medication, also known as Acomplia, is still being tested and isn't on the market. Yet reports about the drug's possible benefits -- which include not only suppressing appetite but also curbing the urge to smoke and improving cholesterol and blood sugar levels -- have many WebMD users clamoring for it. "When can I go on this new great drug?" asked one. "I'm overweight and need help fast!"

The answer is that the drug's manufacturer, Sanofi-Aventis, plans to apply for FDA approval in 2005. A decision by the agency will then take up to 10 months. If everything proceeds smoothly and the FDA gives its blessing, the drug could be on the U.S. market sometime in 2006. The company also hopes to get approval to sell the drug in Europe beginning in 2006.

Plenty of things can hold up or derail drug approvals, though, including concerns about safety, a subject that many WebMD users asked about. So far the main side effects seem to be nausea and dizziness, which were bothersome enough to cause some people participating in studies to drop out. What's more, no one yet knows what risks the medication might pose with long-term use, which appears necessary to keep weight off.

Another common question was how to volunteer for studies. The manufacturer says none is open to new participants.

Few users asked what is perhaps the most important question: Is this really the miracle pill that many news reports have portrayed it to be? Known as a cannabinoid type I (CB1) blocker, it's the first of an entirely new class of drugs, which works by blocking a pleasure center in the brain. From the standpoint of researchers, the drug is clearly a breakthrough.

But from the standpoint of people trying to lose weight, it's something less. Researchers report that people taking the drug for two years lost an average of 19 pounds and 3 inches off their waists, compared with about 5 pounds and 1.5 inches among those who took a placebo. A benefit for sure, but hardly a miracle.

It's worth remembering that the two drugs currently approved for weight loss, Meridia (sibutramine) and Orlistat (xenical), were also once hailed by the media and others as answers to obesity. But they ended up having much more modest effects. And then there's the drug combination of fenfluramine and phentermine, known as fen-phen. Frenzy over fen-phen swept the U.S. until researchers discovered that the drug combo was causing heart valve problems. As a result, fenfluramine and its cousin Redux, another weight loss drug, were pulled off the market.

Rimonabant, perhaps in combination with other drugs, may in fact prove to be a useful tool in the fight against obesity and its adverse health effects. But it's not going to be the magic bullet that many users are evidently hoping for. Their overwhelming response to the WebMD article is a reminder of how difficult and frustrating the battle with weight often is. We owe it to them not to give false hope that a pill -- however promising -- is the answer to their prayers.

Italian researchers presented another curious research for Acomplia. According to them Acomplia also play a major role in reducing breast cancer. According to Maurizio Bifulco of the Università degli Studi di Salerno, research escorted, Acomplia "inhibited human breast cancer cell proliferation" in both gnawer and test tube studies.
Curiosity began when under discovery it has been found that the Acomplia is the most effective drug to reduce the growth of a belligerent metastatic breast cancer cell line called MBA-MB-231. Metastatic spread of breast tumors pays the majority of cancer related deaths.
The researchers told that "The growth of highly invasive metastatic MDA-MB-231 cells was inhibited more efficaciously than that of less invasive T47D and MCF-7 cells".
According to them they applied different doses of zimulti on tumor cells proliferation against very destructive metastatic, estrogen receptor negative MDA-MB-231 breast cancer cells as well as against estrogen receptor positive T47D and MCF-7 cells and found that the drug is giving the positive response of the reduction of breast cancer.
Experiment:
They have done the test on mice by injecting with MDA-MB-231 cancer cells. After 15 days when tumors were clearly observable, the mice are being injected by rimonabant.
According to researchers under test they have found that "Tumor growth was monitored and the data revealed that exposure to rimonabant led to a significant decrease in tumor mass compared to control-treated mice, and also the treated mice with rimonabant exhibited no outward signs of toxic or hypolocomotor effects".
Under the close surveillance they also found that the CB1 receptor exists in greater extent in some lines of breast cancer than in others and the efficiency of rimonabant depends on the levels of CB1 receptor. So, here the points that should be noted are that the degree of rimonabant use to reduce the breast cancer can be varied.
Under conclusion researchers signified that "The present findings provide unequivocal evidence for the role of the CB1 receptor and its antagonist/inverse-agonis t rimonabant in breast tumor cell proliferation".

Bremolanotide, which is meant to stimulate the brain, unlike Viagra, which just aims at what's below the waist. Also, Bremolanotide will come in the form of an inhaler, not a pill. It works for both sexes, but apparently it's going to be marketed towards women, which makes sense.
Bremolanotide, how's this miracle drug supposed to overcome a beer-belching, pot-bellied lump of a husband? What good is a sex drug when the object of one's devotion looks and smells like Al Bundy? Yeesh. A lot of guys will jump on anything that moves when they're gagging for sex, but women aren't built that way, unfortunately

Acomplia Zimulti miracle for all

Acomplia (rimonabant)is a certified product in the UK to treat both obesity and smoking-habit. Clinical studies have established the drug to be effective in reducing craving for nicotine in patients the drug has only at the moment been approved treatment of obesity. As this is a prescription medication we strongly advise consulting your doctor or a certified physician. This information should not be regarded as an alternative to the treatment advice your doctor can provide.

Acomplia (rimonabant)

Acomplia is a magic potion for treating obesity. This weight loss drug has been launched for retailing on prescription in the UK from 21st June 2006. Available in 20mg tablets, it has to be taken daily on prescription of a certified doctor.

You just need to fill a simple consultation form to buy Acomplia.

How does Acomplia work?

Acomplia works on the push for eating more. It works on the endocannabinoid system, a system affecting energy balance, glucose and lipid metabolism and body weight. It obstructs certain receptors in the brain; as a result you experience the feeling of being full in turn eat less than normal. It has been proven be more effective if used in conjunction with a calorie reduced diet and exercise.

How much weight can be lost on Acomplia?

More than 6800 patients have undergone placebo-controlled studies using Acomplia with substantial results. In the subsequent phase 3 trials a dietician prescribed a diet for patients and they were asked to increase physical activity/exercise.

On the completion of a year and taking an Acomplia 20mg pill daily a mean weight loss of 6.5 kg was observed as compared as 1.6 kg with a placebo. The first 9 months were the most crucial in which significant weight loss was achieved.

It was also seen that with Acomplia, the risk to regain weight was much lower.

Acomplia also reduced the risk of weight regaining. In one experiment after one year, a group of patients on Acomplia 20mg were re-randomized to Acomplia 20mg or Placebo and it was observed that patients who continued on Acomplia 20mg achieved a total weight loss of 7.5kg over two years, while the Patients who were transferred to placebo had a total weight loss of 3.1kg over the two years.

There was a sizeable reduction in the waist circumference, an indication of intra-abdominal fat, in patients treated with Acomplia. The waist circumference which is a more important measurement than BMI was said to have reduced by 6 – 7 cm.
Side- effects

Some common side effects, obese or overweight patients were
• Nausea
• Mood alteration with depressive symptoms
• Depressive disorders
• Anxiety and dizziness

The following table shows all the adverse reactions from the four placebo-controlled clinical studies.

Contraindications

Acomplia should be used with caution in patients with the following conditions:

• Moderate kidney problems or problems with urological system
• Patients aged over 75 years
• Epileptic Patients
• Patients using medicines like ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)
• Rare hereditary problems of galactose intolerance

Acomplia should not be prevented in patients with the following conditions:

• Severe kidney or urological problems
• Uncontrolled psychiatric illness such as a major depression.
• Cardiovascular trouble (myocardial infarction, stroke, etc.)
• Breastfeeding mothers
• Pregnant women

How to use Acomplia

Acomplia Rimonabant is a prescription drug to be taken as an adjunct to diet and exercise for the treatment of obese patients with BMI or equal to 30kg/m2 or overweight patients with BMI or equal to 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia.
Patients should take only one 20mg tablet every morning with breakfast.

How to buy Acomplia

Acomplia can be prescribed by a Rimonabant Acomplia doctor following an online consultation. Simply fill in the online consultation form, which will then be reviewed by a Rimonabant Acomplia doctor. You will receive a personalized email diagnosis providing you with a link back to Rimonabant Acomplia from where you can buy Acomplia.

Orders placed before 3pm Monday to Friday will be dispatched same day for next day delivery.

Acomplia (rimonabant) has not yet become a licensed product for smoking cessation in the UK. Whilst during clinical studies the drug clearly demonstrated a reduced craving for nicotine in patients the drug has only at the moment been approved as an obesity treatment. As this is a prescription medication we strongly advise that you seek to have a face-to-face consultation with your doctor in the first instance. This information should not be considered as a replacement to a doctor’s treatment.

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