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2007/7/27

Diet Drug Acomplia Sales Dwarfed by Initial Sales of Diet Pill alli

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@ 09:21 PM (12 months, 3 days ago)

Just how badly sales of diet drug Acomplia (rimonabant) have been set back by Sanofi's inability to bring it to the U.S. market was dramatically illustrated July 25th when GlaxoSmithKline revealed initial launch results for over-the-counter diet pill alli (low-dose Xenical).

Sales of non-prescription alli totaled a surprising $156 million in the weeks after its U.S. launch in mid-June -- a sales surge that dwarfs the monthly sales of Acomplia in all the countries where it is on the market in the European Union.

If most of the alli sales were to people initially buying a one-month supply of the over-the-counter diet pill, the sales figure would suggest that more than 1 million Americans decided to try the first FDA-approved non-prescription weight-loss product in its first weeks on the market.

By contrast, in the European Union, where Acomplia was approved for sale last summer, somewhere between 100,000 and 200,000 are believed to have tried it over the course of a year.

Sanofi had initially hoped that Acomplia -- which was to be sold in the United States as Zimulti -- would be a blockbuster drug with sales that could even exceed $5 billion worldwide.

But without the U.S. market, it appears that Sanofi will be fortunate if sales in Europe and other countries where it has been approved total one-tenth of that.

Glaxo, in announcing sales results for alli as part of its report on second-quarter earnings, said its big advertising and promotion campaign paid off with more than 2.4 billion media mentions since the FDA approved sale of the diet pill in February.

Glaxo also said that it had recorded more than 4.5 million visits to its website -- myalli.com -- making it the third-most visited website for any over-the-counter pharmaceutical product.

Acomplia is currently marketed in 13 European Union nations as well as in Argentina, Mexico and a handful of other countries.

Source: http://www.acompliareport.com/

2007/7/15

Safety of new weight-loss drug is questioned

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@ 10:56 PM (12 months, 15 days ago)
A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, local therapists fear.

Read the rest of this entry ... (564 words left)

2007/7/10

Exercise is safest way to lose weight

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@ 11:06 PM (12 months, 20 days ago)
With obesity on the rise in America, and the lengthy list of medical issues attributed to it, consumers are searching for ways to lose weight. Nothing represents America's desire to lose weight more than the billions of dollars spent each year on weight loss programs.

Unfortunately though, those trying the newest fad diet or diet pill quickly find the money spent doesn't pay off.

Alli is the most recent diet pill to hit the market. Made by the same manufacturer of the prescription diet drug Xenical, Alli is a lower dosage version and can be purchased over-the-counter.

Just like Xenical, Alli is promoted as a weight-loss enhancer by preventing the absorption of fat from foods we eat. And just like its predecessor, Alli does increase the risk of becoming deficient of fat soluble vitamins. Therefore, taking a daily multi-vitamin at a different time than taking Alli is a must.

Alli's manufacturer recommends using the pill in conjunction with making lifestyle changes. These changes include exercising and eating a low-calorie, fat-controlled diet. Since Alli is a fat blocker, the manufacturer recommends eating no more than 15 grams of fat at each meal, or a consumer runs the risk of having negative symptoms (i.e.: gas, loose stools, diarrhea, and more frequent and/or hard to control bowel movements).

Fifteen grams of fat per meal equates to eating 25 percent of one's daily calories from fat when following an 1,800 calorie meal plan (or three meals with 15 grams of fat and one snack with 5 grams of fat). Fat should provide 20 to 35 percent of our daily calories, according to the 2005 U.S. Department of Agriculture dietary guidelines.

Does it work?

Weight loss may occur, but not necessarily in the amount you are hoping. According to Dr. Donald Hensrud, of the Mayo Clinic in Rochester, Minn., although some studies have been done on Alli, most of the weight loss projections are based upon the results of studies done with Xenical. With Xenical creating an average weight loss of only 6 pounds each year above weight loss from diet and exercise, he concludes at "half the strength, Alli could conceivably result in an average of 3 pounds lost in a year."

In the end, I feel the potential positives associated with the use of Alli are heavily outweighed by the negatives. Therefore, I recommend customers save their money and not use this diet aid.

Source: http://www.masslive.com/

2007/6/27

Side effects not slowing Alli diet-pill boom

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@ 10:04 PM (13 months, 3 days ago)

A new over-the-counter weight-loss pill, which has been disappearing quickly from store shelves across Houston since it became available a week ago, is likely to cause undesirable side effects if dieters don't also abide by the low-fat diet that the drugmaker recommends.

That hasn't stopped thousands of people from flocking to pharmacies to buy Alli, the first FDA-approved nonprescription diet drug. For the past week, pharmacy employees have stocked and restocked their shelves with the pills.

"We can't keep up with it," said Hisham Ghali, executive assistant manager of a Walgreens in River Oaks.

The store had sold out of the largest available bottle of Alli on Thursday, but he expected another shipment within a few days.

Alli, pronounced "AL-eye" and manufactured by GlaxoSmithKline, prevents the body from absorbing fat by blocking enzymes in the digestive system. Made using orlistat, which has been available for several years in a higher-dose prescription form called Xenical, Alli blocks about a quarter of the fat eaten during a meal when users pop a pill beforehand. It can be taken up to three times daily.

Users of Alli can lose about 50 percent more weight than they would through dieting alone, according to GlaxoSmithKline. For example, someone who loses 10 pounds through dieting could lose 15 pounds with Alli, the company says.

The drug can cause nasty side effects, however, particularly for dieters whose fat intake per meal is higher than the recommended 15 grams. (A fast-food hamburger can contain 30 grams.) GlaxoSmithKline warns of the potential for "gas with oily spotting, loose stools or more frequent stools that may be hard to control." The company suggests not taking the pill before meals with high fat content.

Users attest to this on Alli's online message board through posts called "accident support group." Some complain of the bowel changes and leaks consistent with GlaxoSmithKline's warnings, while others say they have constipation or cramping. Meanwhile, dieters considering using the drug ask questions such as, "adult diapers mandatory during first week?"

For at least one Alli dieter, the unpleasant side effects are part of the drug's appeal.

"It forces me to diet and exercise to avoid any bad side effects," a dieter who signed in as Sheree wrote on Alli's message boards. "Trust me, on my own I would have already cheated!"

Low-fat diet is crucial

Two local diet specialists said orlistat can be effective, so long as the user is dedicated to a low-fat diet.

"For the person who's committed to eating right and exercising and doing the right things, then staying on Alli will serve them well over time," said Dr. Tom Lux, assistant professor of internal medicine at the University of Texas Medical School at Houston, who has prescribed Xenical for weight-loss patients. "For a person who likes to eat a lot of steak and heavy food and fried food, it's not going to be a good choice."

After a Walgreens in the Memorial area got its first shipment on June 14, buyers bought all 36 packs of 90 pills, at a price of $59.99, that day. The store got a shipment of 60- and 120-pill packs the following day and quickly sold those, too, said store manager Bill Coligan.

"It was a little busy," he said. "Every couple of minutes, we were over here unlocking the case."

'Not a magic pill'

Stores are keeping the product locked because it's so popular, and pricey, that it's a major target for shoplifters who want to sell it on the street. A 60-pill "starter pack" sells for $49.99, while one with 120 pills goes for $69.99.

The drug also is selling well at other local pharmacies, including CVS and Kroger.

Rebecca Reeves, a dietician and assistant professor at Baylor College of Medicine who has conducted research on orlistat, said having the drug available over the counter provides a great opportunity for people looking to lose weight.

"It's not a magic pill," she said. "It will help you along when you are involved in a good, healthy lifestyle."

Source: http://www.chron.com/disp/story.mpl/front/4914080.html

2007/6/19

Alli hits the stores

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@ 09:34 PM (13 months, 11 days ago)

The first non-prescription diet drug ever to be approved by the FDA hit the shops this week and optimistic dieters are dashing out to buy it.

The new diet pill, Alli which is manufactured by GlaxoSmithKline (GSK) works by blocking the absorption of fat by the body which is then eliminated by way of the bowels.

The drug does have some unpleasant side-effects such as oily bowel movements, loose stools and the possibility of leakage, along with gas.

A months supply of Alli will set you back US$60 and GSK recommends the best results will be achieved when no more than 15 grams of fat per meal are eaten while taking the drug.

Alli is not recommended for people younger than 18, people with kidney disease, or people on blood thinners.

In a study, Alli taken in conjunction with a good diet, offered an additional 5% of weight loss when compared to somebody following a good diet without taking the drug.

Only 20% of people who use Alli can expect to lose 10% or more of their body weight and many will lose very little weight and possibly suffer the embarrassing gastrointestinal side effects.

Unlike other prescription weight-loss drugs Alli does not induce a feeling of fullness, reduce cravings or curb the appetite; what it does do is prevent the body from breaking down and absorbing fat.

The active ingredient in Alli, orlistat is also found in the prescription diet drug Xenical but in a higher dosage.

While Alli blocks around 25% of the fat eaten, Xenical blocks one-third of the fat ingested.

In real terms 2,000 calories a day with about 30% fat, would translate to about 150 calories a day with Alli.

A pound of weight loss equates to 3,500 calories.

Limiting fat intake to 15 grams a meal will help avoid the side-effects - .most Americans consume 80 to 100 grams of fat a day.

Glaxo officials do admit that many people would lose weight on their own with a reduction in fat intake, but say that Alli helps people lose more weight.

Doctors say most people are eating far more fat than they realize and the case with most dieters is that are unable to sustain the weight loss.

Orlistat has been widely tested and about 50% of the people who use orlistat lose at least 5% of their body weight; only one out of five people who take the drug lose at least 10% of their body weight, according to Glaxo.

Experts say even small amounts of weight loss offer health benefits.

Source: http://www.news-medical.net/?id=26566



2007/6/11

GlaxoSmithKline Launches $150 Million Effort For Alli

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@ 08:34 PM (13 months, 19 days ago)
GLAXOSMITHKLINE (GSK) CONSUMER HEALTHCARE HAS launched the first salvo of its $150 million effort for Alli, the first FDA-approved over-the-counter weight loss drug in years. The effort for Alli (pronounced like ally) launched on May 22 in New York City. The company took over the vaulted-ceiling main room of 20 Union Square for its multimedia exhibit called Alli Experience.

The central tenet of the experience--and of the drug, which goes on sale mid-June--is gradual weight loss and a "don't expect miracles" approach embodied by the tag, "Your will. Our power."

The compound, an attenuated version of prescription drug Xenical (Orlistat 120mg), works by inhibiting the function of intestinal enzymes that facilitate the body's absorption of fat. The company says it blocks the absorption of about a quarter of the fat one consumes. GSK will sell Alli in product packets that include a 30-day supply and a series of books including calorie counters, diets and recipes, lifestyle tips, and a diary.

Since the compound--intended to be taken three times daily--is being pitched as a companion to dieting rather than a replacement for it, the company's marketing and the exhibit attack fad and crash diets and repeat, in different forms, the mantra that dieting is a commitment that takes time, pill or no pill.

The first area of the exhibit is a passage flanked by video screens playing clips of miracle diet ads and stories debunking them, while speakers play a cacophonous loop of quick-diet pitches.

The next space is a bench next to a wall of sayings like "there are no shortcuts." There's an interactive section featuring tables with Mac computers letting one view content on how Alli works, on dieting, etc., and there are areas featuring examples of various dishes and snacks--some healthier than others--with big turntables showing real food under glass and their respective caloric and fat content.

A dietitian and pharmacist are also on hand. Visitors leave with a shopping bag of brochures, games, surveys and a book, Are you Losing It? The book is for sale in pharmacies and bookstores for $5.99, the proceeds going to child obesity charities.

Joe Cadle, Marketing Director/Weight Control of GSK Consumer Healthcare, says that although GSK positions the treatment in contradistinction to compounds claiming to "melt off the pounds," the competition is not miracle drugs--because, he says, people who reach for quick and easy solutions to weight problems won't be interested in Alli. "People who tend to buy miracle drugs are looking for a quick fix, so we aren't competing with them. Our efforts are positioned against those selling to consumers committed to doing the hard work."

Says Cadle: "When you take a look at the messages out right now, a lot of products are being marketed as miracle fixes: 'Lose 20 pounds in two weeks!' Alli is about changes toward a healthy lifestyle that require a commitment."

Cadle says the marketing group realized, through consumer research, that consumers have no clue what the difference is between an FDA-approved compound and any number of so-called diet drugs lining shelves and being promoted in ads. "People intuitively don't trust these things any more--they hear these claims, and know they are not true. We want to be an honest voice in a category known for hype. The truth is, losing weight is hard ... and that resonates." He explained that Alli is intended to offer a kind of bonus for the work of dieting via extra "bonus" weight lost. "One woman in a focus group says those extra five pounds would be priceless."

Debbie Weis, GSK Consumer Healthcare senior brand manager, says that, depending on the response to the Alli Experience in New York, which ended last week, the company plans to have additional programs in other markets.

One of the staff pharmacists says as many as 1,300 people have come through on a given day, with many of them asking questions about the effect of Alli on diabetes and cholesterol-lowering drugs. Cadle says GSK is doing targeted efforts via sales teams and targeted communications to physicians on specific health issues.

Overall, per Weis, about 5,000 people have come through the exhibit since the opening. "They are spending around 10 minutes in the space, on average. That's more than we expected."

The company began running a "drive-to-web" 30-second TV spot earlier this month, and Cadle says that the Alli Web site, myAlli.com, has garnered 1 million unique visitors since launch.

Per Cadle, this month GSK will launch a 60-second TV commercial and will ramp up Internet efforts. Print efforts will include 15 million four-page inserts in July and August issues of women's magazines with an "accordion-fold" pull-out.

"From a marketing perspective, we are developing content that can travel, content you can carry--we want to educate consumers at every possible touch point [about] where they can find Alli," he says.

Display kiosks at pharmacies and stores selling Alli will be focused less on product pitch than education and self-inquiry about will power, Cadle says--with brochures on lifestyle and diet choices, assessment tests, even a telephone at some retail points that have audio challenging consumers to think about whether they are willing to make the commitment. The company is also running video content on YouTube.

Consumers can purchase the Alli starter kit for $49.25 for a 60 capsule-count starter pack and for $62.99 for a 90-capsule starter pack, per a GSK spokesperson. However, the retail cost of the product in stores may vary a little based on the individual retailer promotional plans.

Source: http://publications.mediapost.com/

2007/5/24

Marketer Of New, First FDA-Approved OTC Diet Pill (alli) Takes Different Approach

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@ 08:15 PM (14 months, 7 days ago)

The marketers of alli, a GlaxoSmithKline manufactured drug, will provide consumers with the first Food and Drug Administration (FDA)-approved over-the-counter weight loss product without a prescription as it hits store shelves this summer (2007).

However, first they are debuting the "diet pill" with an exhibit in New York City to educate the public about their product, which is being touted as a safe and effective drug that won FDA approval in February.

This product is for any adult who is overweight. However, the manufacturer and its marketing company are taking a different approach than that of the drug, Xenical, which has twice the potency of alli.

First, the educational promotions are being forthright with information, such as the facts that there is no "magic" diet pill, and that people who use alli must also make a concerted effort to eat a reduced-calorie, low-fat diet, and exercise regularly.

If these efforts are made while using the drug that manufacturer's claim only affects the gastrointestinal system, then results will be seen.

The FDA noted that people using alli lost an additional two to three pounds for every five pounds that were lost by dieting and exercising.

According to the manufacturer, "alli helps people lose 50 percent more weight than with diet alone."

When alli is taken along with meals, the effective process blocks absorption of nearly one-quarter of the fats consumed (approximately 150 to 200 calories), which are then passed right out of the body.

However, this affect can result in loose bowels. Nearly 50 percent of trial study participants experienced gastrointestinal side effects (including bowel leakage and oily discharges) with the use of alli.

In fact, these unpleasant side effects are why the company is stating how important it is to use the drug properly and count fat gram intake.

In addition, the educational literature even recommends that users of the product should really start the program in conjunction with time off from work.

The drug includes a "starter kit," a food journal, a healthy eating guide, a fat and calorie reference guide, and 60 capsules of alli. The recommended dosage is one to three pills per day. A total of 60 capsules will cost about $50, whereas 90 capsules will cost about $60.

Since the late 1980s, adult obesity has steadily increased in this country, according to the FDA that began to formulate a plan to tackle the problem.

Currently, two out of every three people in the U.S. are considered overweight or obese, according to an AP report

Source: http://www.allheadlinenews.com/articles/7007429094


2007/5/22

alli™ debuts through the alli Experience

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@ 08:39 PM (14 months, 9 days ago)
GlaxoSmithKline Consumer Healthcare [NYSE:GSK] introduces a new approach to weight loss that will debut through a public multi-media exhibit in New York City— the alliTM Experience. The alli Experience represents part of GSK Consumer Healthcare’s comprehensive educational program to prepare adults interested in losing weight with alli — the only over-the-counter weight loss product approved by the U.S. Food and Drug Administration (FDA) — before it goes on sale in pharmacies and mass retailers beginning on or about June 15. The alli Experience will be open daily beginning Tuesday May 22 through Sunday June 10, 2007, and is open Monday through Fridays from 11 a.m. until 6 p.m., Saturdays from 10 a.m.until 6 p.m.and Sundays from 11 a.m.to 5 p.m.The exhibit is located in New York City at 20 Union Square East (located at the Southeast corner of the Square).

More than two-thirds of the U.S. population is overweight or obese, resulting in increased risk for serious diseases such as heart disease, diabetes, cancer and stroke. These serious health complications require the American public to take an honest look at the realities of weight loss. “We’re here today to unveil the alli Experience and demonstrate our commitment to changing the way people think about weight loss.” says Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare. “People are fed up being bombarded with hyped products and fad diets that over promise and under deliver. Unlike all the hype, alli is about straight talk and an honest voice, being real about the fact that losing weight is hard work.” Burtonadds, “We’re here to help and to partner with people who want to lose weight with a realistic approach. But we’re not the total answer. The answer is individual commitment in partnership with alli, and all the support and education the alli program offers.”

The alli Experience is designed to help overweight people revisit and engage the principles of modest, gradual weight loss. The exhibit, divided into five zones, begins with a sensory tour that leads to an interactive journey and multi-media education about weight loss realities. Each zone encourages visitors to embrace a more realistic approach to diet and exercise for improved health. Visitors receive meal planning ideas, delicious low-fat recipes and shopping lists with nutritious foods to help support a healthier lifestyle. The alli Experience will also help overweight people who want to lose weight determine if they are ready to commit to the alli program.

Zone 1: You enter a surround-sound passage of empty promises — “guaranteed, miracle pill, easy, no carbs!” Bombarded by chaos and hyperbole flashing on ceilings and walls, you’re asked, “Fed up?”

Zone 2: In contrast to Zone 1 you enter a more serene space… classic, clean, clear. To match the simplicity of the message is one lone bench. Above it you read sound advice — there are no shortcuts. Tenets of truth inscribed on the wall acknowledge and inspire — losing weight is hard but not impossible. Need help? Engage in the next Zone.

Zone 3: Enter a theater of interactive stations to ask, learn, and discover. Find out if you’re ready for a true weight loss commitment or still looking for a quick fix. Learn how alli can be a partner to help you lose 50 percent more weight than dieting alone… understand that you can’t just try alli, you have to commit to it. Test yourself to see if you’re ready to commit.

Zone 4: Feast your eyes on a larger-than-life sized dinner plate featuring projections of appetizing dishes that challenge your dietary aptitude. See carousels showcasing flavorful low-fat meals and learn how to keep temptation out of your pantry in a simulated kitchen. Encouraged? Reflect in the next Zone.

Zone 5: At interactive kiosks, embark on a personal journey to find out what’s holding you back... exercise your option to speak to a trained expert. Exit the alli Experience… and enter a new weight loss revolution. You. Your commitment.

The alli Experience is open to anyone who is 18 years or older, as alli is for overweight adults.

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2007/5/2

The Skinny on Alli

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@ 01:58 AM (15 months, 2 hours ago)

Could the first FDA-approved, over-the-counter diet pill jump start weight loss for overweight Americans?

For years, dieters across the nation have turned to drugstore aisles in search of a quick fix for their weight problems. Hundreds of bottles of supplements and diet pills line these aisles, and most use catchy advertisements and testimonials to make what many doctors say are unsubstantiated claims -- fooling dieters into believing that a bottle of pills could help them lose 10 or 20 pounds in a matter of days or weeks.

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2007/5/1

New Miracle Diet Pill Doubles Metabolism

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@ 01:49 AM (15 months, 1 day ago)
A new exercise pill turns your body into a fat-burning machine allowing it to burn twice the fat.

The pill has been developed by American scientists and to this point stil does not have a name. The pill is in early stages of development but could cure the obesity crisis in America as well as the world.

The pill has been tested i mice thus far. The pill allowed the mice to eat a very high-fat diet without gaining an ounce. This would be a major break-through as it would allow more freedom in the diets of fast-paced peopel around the world.

The pill works by triggering the same type of fat-burning processes which occur when you go to the gym or go for a run. This exercise can be doubled by taking the pill. When they are not active, the mice continued to burn fat.

Dr. Ronald Evans stated “Too few people get an ideal amount of exercise. Having access to an exercise pill would improve the quality of muscles, and increase the burning of energy or excess fat lowering the risks of heart disease and diabetes.”

The rule of thumb is as long as more calories are burned than taken in, you will lose weight.

Source: http://www.ecanadanow.com/