Claims that an anti-obesity drug offers benefits outside those associated with weight loss may not be justified, experts have said.

Rimonabant (brand name Acomplia ) has been described as the "new wonder slimming drug", with trials showing it helps obese people shed excess pounds.

The National Institute for Health and Clinical Excellence (Nice) is currently appraising the drug for use on the NHS.

But experts writing in the Drug and Therapeutics Bulletin (DTB), from the British Medical Journal (BMJ), questioned claims by the manufacturer, Sanofi-Aventis.

They said there was no proof that the drug had any beneficial effects outside those expected by weight loss.

According to the Sanofi-Aventis website, the drug "has a beneficial effect on blood glucose and lipid levels - a more beneficial effect than would be expected from weight loss alone".

Advertisements for the drug have suggested that half of the drug's effects on cardiometabolic risk factors are beyond those expected by weight loss alone.

Cardiometabolic risk relates to factors that can be combined to heighten a person's chance of developing heart disease and/or type 2 diabetes.

Such factors include obesity, "bad" cholesterol, fat levels in the blood, high blood pressure and insulin resistance.

The DTB researchers also said the drug had not been effectively compared with other, cheaper drugs for weight loss. They cited Xenical (orlistat) and Reductil (sibutramine), which cost less and are approved for use on the NHS.

Source: http://icberkshire.icnetwork....;

How is it possible that mid-sized Indian pharmaceutical companies are already selling their own versions of diet drug rimonabant in India while the original developer of the drug, Sanofi-Aventis, still doesn't have Indian government approval to sell Acomplia?

Well, part of the answer may be that Sanofi was so focused on getting approval to sell the drug in Europe (where Acomplia went on sale last summer) and in the United States (where it still awaits regulatory action) that the French pharmaceutical giant was late in filing for marketing authorization in India.

While a Sanofi spokesperson said the company filed last summer with India's Central Drugs Standard Control Organization, which regulates the market authorization of new drugs as well as the standards for imported drugs, Sanofi confirmed that the Indian regulatory agency has not yet acted on Acomplia.

"It's too soon to tell what will be our strategy regarding the launch of Acomplia in India,'' a Sanofi spokesperson told Bloomberg News last week.

Given the relatively high cost of the drug -- generally somewhat more than US$100 per month -- in the dozen plus countries where Acomplia is already on sale, Sanofi may have thought the number of Indians who would be able to afford a price of this magnitude would be relatively small.

But in the meantime, Indian pharmaceutical companies that seem to have replicated Sanofi's version of the rimonabant molecule -- which apparently was never granted patent protection in India -- independently filed with the regulatory agency and received approval to sell their own versions of the drug.

With at least two companies -- Torrent Pharmaceuticals and Zydus Cadila -- already selling Rimoslim and Slimona in India for under US$6 per month, the market for rimonabant in a country that has a growing urban, middle-class obesity problem may turn out to be significantly greater than Sanofi believed.

Source: http://www.dietdrugreport.com...;

In the middle of the Avandia blowup, GlaxoSmithKline this week is launching the new over-the-counter diet pill "Alli ." The company says it's spending 150 million bucks on the first-year marketing of the formerly prescription-only Xenical from Roche.

A big chunk of that is going toward a multi-pronged educational campaign to convince dieters they have to change their eating habits and exercise if they want to get the maximum benefit from Alli. That's crucial with this drug because the more fat you eat, the worse the gastrointestinal side effects. Clue: Glaxo is telling Alli users to wear dark pants and bring an extra pair to work. The company has gone so far as to set up an exhibit in New York City this week where people can get more information about Alli.

But if the side effects don't sound appealing, dieters can eat less and exercise more and/or wait a couple months. Sanofi-Aventis is waiting for FDA approval of its diet pill formerly known as rimonabant and Acomplia and now being called "Zimulti." That's right... Zimulti.

Apparently, the FDA balked at the proposed name of Acomplia because it sounded either too much like "accomplish" or like an existing drug on the market. How they went from Acomplia to Zimulti (from A to Z), though, is beyond me.

Anyway, the middle of next month, the drug goes before an FDA Advisory Committee. And the FDA is scheduled to make a decision on whether to approve it by the end of July. So far, tests show it helps people lose weight without any nasty gastrointestinal side effects. But questions have been raised about more patients on Zimulti reporting feeling depressed versus those who were on the placebo.

Meantime, there's more news regarding Avandia. The British medical journal, The Lancet, is pooh-poohing the Avandia study in The New England Journal of Medicine. The Lancet writes in an editorial published online today that "...it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses. To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of (Avandia) is needed. Alarmist headlines and confident declarations help nobody."

A meta-analysis is essentially a review of data from a bunch of clinical trials. It is not considered the gold standard in medical research. That said, the Cleveland Clinic's Dr. Steven Nissen, who did the meta-analysis, stands by his findings.

Source: http://www.cnbc.com/id/188244...;

Diet pill alli (low-dose orlistat) will officially go on sale on June 15th, according to distributor GlaxoSmithKline Consumer Healthcare.

While the pricing of the drug has not been officially announced, a starter pack that includes 60 alli capsules (enough for three weeks assuming that you take one before each meal), the alli Shuttle (a carrying case for your pills), and several booklets including a calorie and fat counter and a daily journal is expected to cost between $50 and $60.

An alli starter pack that includes 90 alli capsules (enough for a month assuming that you take one before each meal) is expected to cost between $65 and $70.

An alli refill package -- consisting solely of 120 alli capsules (enough for 40 days) -- is expected to cost between $75 and $85.

Glaxo, meanwhile, has released the first two television commercials of what is ultimately expected to be a $100 million plus first-year blitz for the first FDA-approved over-the-counter diet drug.

Both of the first two commercials can be viewed by those who have missed them on television via the video sharing website YouTube.

As part of the prelaunch educational campaign for the diet pill that Glaxo agreed to at the insistence of the FDA, the first two commercials are very slick but soft-sell and are designed to push people to Glaxo's internet website, myalli.com, which is expected to play a major role in the company's marketing.

Source: http://www.dietdrugreport.com...;

Diet pills come and diet pills go, but still the fat clings to the collective hips and bellies of 167 million of us in the United States.

Two pharmaceutical companies are hoping that two new drugs under review by the Food and Drug Administration might do what dozens before have tried but failed to do - expunge us of some of our fat, without killing us in the process. Dozens of drugs over the years have held great promise but few have had lasting results.

"The whole history of weight-loss drugs has been very disappointing," said Morgan Downey, executive director of the American Obesity Association. "It will be interesting to see what happens with these."

One drug, rimonabant, was approved in Europe in June. It is available in the United Kingdom, being marketed as Acomplia . It would be available by prescription only.

The second weight-loss drug before the FDA is for over-the-counter usage. It, too, works differently than appetite suppressants, but not the way that rimonabant does.

Alli (pronounced AL-lie) blocks the body's absorption of fat. It is a lower-dose version of the prescription drug Xenical, or orlistat, as it is known generically, which has been on the market since 1999.

Some things to know about diet drugs

Acomplia Rimonabant Blocks brain receptors

Has shown in clinical trials to lower cholesterol and triglyceride levels; manufacturer says it can significantly reduce abdominal obesity, a marker for heart disease; prescription would be required; FDA has not approved drug

Alli Orlistat Blocks absorption of fat

Has been on market for prescription use for almost a decade; to be used in concert with exercise and dietary changes; if approved, no prescription would be required for Alli; can cause cramping, diarrhea, flatulence, intestinal discomfort and leakage of oily stool. FDA approval of prescription version, Xenical , granted in 1999.

Sibutramine Meridia

Increases levels of certain brain chemicals that may suppress appetite

Should not be used by people with history of heart disease, high blood pressure, irregular heartbeat, congestive heart failure. May cause headache, dry mouth, constipation and insomnia. Approved by the FDA in 1997.

Bontril Phendi-metrazine tartrate

Appetite suppressant

Should not be used long-term; not advised for people with heart disease; approved in 1982.

Desoxyn Methamphe-tamine

Appetite suppressant

For short-term use only; not advised for people with heart disease or with a history of drug dependency; approved in 1959.

Lonamin and Adipex-P Phentermine

Appetite suppressant

Was the "phen" in "fen/phen," which was pulled from the market in 1997 because the "fen" ingredient, fenfluramine, was linked to the development of valvular heart disease and primary pulmonary hypertension. Short-term usage only. Approved in 1959.

Source: http://www.azcentral.com/heal...;

After more than a year of asking, we now have Sanofi's official explanation why diet drug rimonabant -- sold as Acomplia in Europe and the rest of the world -- will be marketed in the United States (if and when it is approved) as Zimulti.

According to Hanspeter Spek, Sanofi's executive vice president for pharmaceutical operations, the FDA office that passes on proposed names of drugs had "reservations" about the name Acomplia.

"This division considered that Acomplia could be too descriptive or eventually misleading indicating that a patient taking Acomplia would acomplish his therapeutical target," Spek said on a conference call.

"We proposed other trademarks and the FDA agreed finally on Zimulti," Spek added.

Source: Acomplia Report 

US scientists have devised a drug that can switch on a gene to burn body fat, offering hope of an exercise pill.

Mice given the drug burned off fat, even when they did not exercise, and were resistant to weight gain despite a high-fat diet.

The ultimate use would be to treat people at risk of obesity-related diseases like diabetes, rather than offer a "no-work six-pack" pill.

The Salk Institute team presented their work at Experimental Biology 2007.

The drug mimics normal fat and chemically triggers a gene switch called PPAR-delta.

Turning on this switch activates the same fat-burning process that occurs during exercise.

Lead researcher Dr Ronald Evans believes the same will occur in humans.

Human trials

UK expert Dr Fredrik Karpe, from the Oxford Centre for Diabetes, Endocrinology and Metabolism, is hoping to test this in the near future.

Commenting on the work, he said: "There has never been a method to 'medically' switch on fat burning before.

"The finding that PPAR-delta co-ordinates this process, not only by switching on fat burning, but also to rebuild the muscle in a way making it more fit for fat burning, is of major interest, not least as a completely novel approach for the treatment of the metabolic derangements accompanying obesity."

But he cautioned; "Although this might become an 'exercise pill', it is unlikely to provide all the other benefits of real physical exercise."

Source: http://news.bbc.co.uk/1/hi/he...;