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By Jennifer Brett

The Atlanta Journal-Constitution

Women with 50 to 100 pounds to lose and a desire to do so in front of rolling cameras might check out today's open casting call for "The Revolution." Brought to you from the producers of “The Biggest Loser” and  “Extreme Makeover: Weight Loss Edition,” the ABC show will meet potential new talent from 10 a.m. to 4 p.m. today at the Georgian Terrace hotel, 659 Peachtree St. in Midtown. You'll need to bring a nonreturnable photo. The casting folks are looking for people who not only want to lose weight, but who also have inspirational tales to share. If you can cry on cue, so much the better.  For full details see TheRevolutionCasting.com.

Chris Pizzello, AP Charlie Sheen is in Atlanta and keeping a low profile. He's with his ex-wife Denise Richards, who’s working on a Tyler Perry project.

Overscene

Another week, another batch of high-profile sightings. Here's a rundown of who went where this week:

John Travolta was spotted this week at Market in Buckhead, at the Brookhaven Starbucks and at Taka, a sushi restaurant. He’s in town filming a thriller called “Killing Season,” which also stars Robert De Niro. While the shooting is taking place in the north Georgia mountains (the film is set in the Appalachians) Travolta keeps popping up around Atlanta.

We’ve gotten a number of sighting reports at STK, a swank new steakhouse in Midtown. Actor Mehcad Brooks (”Necessary Roughness”), rapper Nas, Carolina Panthers quarterback Cam Newton and “Vampire Diaries” cast members Nina Dobrev and Ian Somerhalder have all been by recently.

And Megan Hilty of the new NBC series “Smash” was in Park Tavern in Midtown with a group of friends.

A lower profile for the "Warlock" this time around

Last April, actor turned YouTube star and Twitter trending topic Charlie Sheen brought his bizarre "Violent Torpedo of Truth" tour to Atlanta. "Things started getting ugly fast," my colleague Rodney Ho, who covered the incomprehensible event at the Fox Theatre, reported at the time.  (We flipped for and he lost the coin toss, so I dodged the bullet. Winning!)

Anyway, Sheen’s been back in Atlanta in recent days, but kept a much lower profile this time. He tagged along with ex-wife Denise Richards, who’s been here working on Tyler Perry’s latest project, “Madea’s Witness Protection.” Their kids were here, too. While Sheen and Richards endured a bitter divorce and custody battle, they've mended fences for the sake off their children. In recent months Richards has discussed their post-marriage relationship, saying they're able to remain friendly now. “We’ve actually become like brother and sister, we really have,” she told Access Hollywood. “I think [the key is] making it about the kids. The stuff between the couple — if you’re divorced — it’s no longer about you anymore. You have to be the bigger person and make it about the kids and so that’s what we’re doing.”  Earlier this week, Richards tweeted a photo of a floral bouquet with the caption, "Mr. Tyler Perry makes sure we have fresh flowers in our trailer every week…so lovely!” Meanwhile, a source spotted Sheen Wednesday night running a pretty mundane errand in Buckhead. He looked very thin but was pleasant and soft spoken, our tipster said.

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Open casting call today for ladies who want to lose

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Golden, CO (PRWEB) February 17, 2012

New Ultra-Concentrated MX-LS7™v2 from iSatori Technologies (http://www.isatoritech.com/MXLS7v2) is a new, significantly stronger, concentrated version of the original high-performance fat burner that has helped over two million people lose weight and get ripped since it was first introduced in 2002.

This new, more powerful, state-of-the-art MX-LS7 formula was totally re-engineered by iSatori with never-before-seen ingredients, which scientific studies have shown help destroy fat cells by converting resistant, ”stubborn” white cells into usable, ”dissolvable” brown cells—to help users strip away stubborn bodyfat, fast.

“All fat burners today are designed with ‘old school’ ingredients that target the wrong fat—white cells. New MX-LS7 v2, on the other hand, is the first weight-loss agent ever designed to ‘reprogram’ fat cells, forcing fat cells to literally ‘self-destruct,’ by converting white cells into brown cells, and thereby rapidly alter your body composition—by helping you reduce stubborn bodyfat versus lean muscle," explains Stephen Adele, CEO and founder of iSatori Technologies (http://www.isatoritech.com/MXLS7v2).

iSatori scientists worked tirelessly to uncover the latest ground-breaking research on three ingredients never before seen. These ultra-potent thermogenic (i.e., fat-burning) ingredients, which are exclusive to iSatori’s proprietary formula include Hemodren™ (a proprietary form of Hemerocallis), Brassical™ (a proprietary form of Brassica), and Red Dralion™ (a proprietary form of Sceletium, being deemed as the “geranium replacement”).

“These ingredients have been carefully researched and combined in specific ratios to help strip away stubborn bodyfat, fast, inhibit the uptake of fat, and radically influence energy and mood, while suppressing your appetite for total fat destruction. And it does this extraordinarily fast!” explains Adele.

But though clinical trials are important, they aren’t enough. Consumers rely on real-world results, with real people (not paid endorsement athletes). “As proof, Dewey Whitworth, even at the age of 52, was able to strip away stubborn bodyfat and get ripped and ‘competition-ready,’ using MX-LS7 v2 as part of the pilot testing program. If he can do it, so can you. Dewey’s proof of how fast our new MX-LS7v2 works—even on the most stubborn fat!” says iSatori Marketing Manager Sue Mosebar.

Ultra-Concentrated MX-LS7 v2 is already in high demand and will soon be available in select markets, so be sure to ask your favorite retailer if they have it. If you can’t find it, you can learn more about the Ultra-Concentrated MX-LS7 v2, or find your nearest retailer, by calling iSatori Technologies direct at 1-866-688-7679 or visit their website at http://www.iSatoriTech.com/MXLS7v2.

Retailers interested in carrying Ultra-Concentrated MX-LS7 v2 should contact Europa Sports, America's largest sports nutrition distributor, at 1-800-447-4795, or visit http://www.EuropaSports.com

About iSatori Technologies:
Based in Golden, Colorado, iSatori Technologies was founded in early 2002 by Stephen Adele to provide clinically tested nutritional supplements and is the only company dedicated to providing complete dietary and exercise solutions for building a better body and living a healthier, richer life. iSatori's performance-enhancement, weight-loss, and muscle-building supplements, such as Eat-Smart®, MORPH®, Liquid Morph+, PWR™, Amino-Phase™, Isa-Test™, Lean System 7®, Energize®, MX-LS7™, Curvelle, and RestorAid™, are available in over 31,000 retail stores nationwide, including GNC and online at drugstore.com, as well as in 17 countries. iSatori recently received the industry's NBJ Gold Award for Growth in Small Companies category. For more information about iSatori and their scientifically proven products, or to receive free nutrition or exercise advice, visit their website at http://www.isatoritech.com, or call one of their fitness experts at 1-866-688-7679.

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iSatori Once Again Revolutionizes Fat Burning With the Release of New Ultra-Concentrated MX-LS7™ v2

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It can be difficult to maintain a new fitness routine or diet, but UC’s Dan Carl, PhD, says tracking specific data can help people get a basic idea of their body composition—and may provide encouragement to stay with a routine over time.

Carl, an assistant professor of clinical rehabilitative sciences at UC’s College of Allied Health Sciences, recommends keeping track of several body measurements to get a complete picture of your weight loss.

"The standard fitness measurements should include height, weight, body fat percentage and body mass index (BMI),” he says. 

Focusing on just one measurement like weight or BMI can be misleading, says Carl, "but monitoring all the measurements gives a true indication of where you’re at.”

Body fat percentage can be measured with some high-tech scales, skin fold calipers or a simple tape measure, while BMI calculators are available online.

Though BMI can’t tell how much of a person’s weight is fat and how much is muscle, it can serve as a fairly reliable indicator for most people over time. According to the CDC, a BMI between 18.5 to 24.9 is considered normal, while a BMI 25-29.9 is considered overweight. The BMI ranges for adults are the same for both men and women. 

Body fat percentage is especially clarifying, says Carl, as it goes beyond the surface. While a large, athletic man could be listed as overweight or obese by BMI charts, he may have a low body fat percentage. Similarly, a woman who looks thin but never exercises may store her extra weight as fat. 

Average body fat percentage for men is between 13-17 percent and between 20-27 percent for women. High is classified as 17-25 percent for men and 27-31 percent for women.

While exact measurements can be taken by doctors, personal trainers or at sports performance labs, careful work with a tape measure at home can be just as helpful when documented regularly.

"My best advice for the person beginning a fitness routine would be to write it down,” says Carl. "Keep a log of your diet and fitness numbers—you’ll start to see patterns and it can help you attach yourself to the routine. That will help with keeping to your new diet and goals in those first few weeks.”

Carl also recommends some perspective—saying those starting or trying to maintain a new fitness regimen should commit themselves to "the long haul.”

"People can put on 20 pounds in 20 years, but who looks at losing that weight over 20 years? If you think about making minor changes to your lifestyle and think long-term about taking off the weight, you’re more likely to be successful,” he says. "Don’t be fooled by what you see in two to three weeks—take a year or two to lose significant weight.”

Provided by University of Cincinnati (news : web)

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Use multiple measurements to track weight loss

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Weight Loss Influenced by Team Support, Researchers Say

Feb. 17, 2012 -- Weight loss may be influenced by joining a team.

A new study shows that people who shed at least 5% of their initial body weight during a weight loss competition were likely to be on the same teams. Those who said their teammates played a large role in their weight loss were more likely to lose a significant amount of weight.

The findings appear in Obesity.

Shows like The Biggest Loser often have team-, family-, or couples-based competitions that harness the power of peer influence when it comes to weight loss.

“People around us affect our health behaviors,” says researcher Tricia Leahey, PhD. She is with The Miriam Hospital’s Weight Control and Diabetes Research Center and is an assistant professor of psychiatry and human behavior at Alpert Medical School of Brown University in Providence, R.I.

This is true for healthy and unhealthy behaviors. “It could be quite beneficial if a bunch of friends that choose to lose weight make healthy food choices together, and hold each other accountable to those choices,” she says.

Team members can motivate one another to stay the course. “If someone is doing really well, it could influence the whole group,” Leahey says.

The findings are based on the results of the 2009 Shape Up Rhode Island campaign, a 12-week statewide, online weight loss competition. Participants competed against other teams for weight loss, physical activity, and the number of steps taken. The weight loss arm included 3,330 overweight or obese people on 987 teams. The teams had between five and 11 members.

Two of the study’s co-authors, Rajiv Kumar, MD and Brad M. Weinberg, MD, are co-founders of ShapeUp, Inc.

There Is No ‘I’ in Team

People who lost at least 5% of their body weight, which is an amount that is thought to be significant in improving health, tended to be on the same teams. Those who reported a higher level of social influence by their teammates increased their odds of significant weight loss by 20%. 

“This is really quite powerful,” Leahey tells WebMD. "We were surprised by the magnitude of the effect."

Team captains lost more weight than team members. This may be because they were more motivated and engaged in the contest.

Kevin Sloan is the acting psychology director at Beaumont Weight Control Center in Royal Oak, Mich. The findings mirror what he sees in his practice. “We find that when couples begin their weight loss journey together, they tend to do better. There is a lot of credence to the buddy concept,” he says.

Not everyone is a team player. “It is important to do a self-assessment before signing up, but this a good approach for some people who are joiners and do much better as part of a group,” he says.

Weight Loss Is Contagious

“People do better in a group because of the peer pressure,” says Louis Aronne, MD, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center.

And “virtual” weight loss works, too. Groups can get together via the web. “Social support helps people to do better, and there are a variety of ways to accomplish it,” Aronne says.

Still, group dynamics can backfire. "When someone is not doing very well, sometimes that person gets pulled along and sometimes they don’t,” he says.

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Want to Lose Weight? Try Teamwork

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Adherence seems to be the hardest part of dieting, but if you can follow through with basic calorie restriction, you will lose the weight.

Strict adherence to eating a certain proportion of carbs, fat, and protein may not be as effective for weight loss as strict adherence to eating fewer calories from all sources, according to a new study that compared four diet regimens.

In the Pounds Lost trial, researchers at Pennington Biomedical Research Center in Baton Rouge, Louisiana, set out to study whether the composition of a weight loss diet affected the loss of lean body mass, total body fat, visceral fat, liver, or abdominal fat. Over 400 overweight or obese men and women were randomly assigned to follow one of four diets: average protein, low fat, higher carbs; high protein, low fat, higher carbs; average protein, high fat, lower carbs; or high protein, high fat, lower carbs.

Low fat was defined as 20 percent of calories coming from fat, while the high fat diets derived 40 percent of their calories from fat. High protein diets had 25 percent of calories from protein while low protein diets were defined as 20 percent of calories from protein. Average protein was considered 15 percent of calories from protein.

All of the diets were designed to be low in saturated fat and cholesterol, high in fiber, include low-glycemic carbohydrates, and reduce intake by 750 calories per day. Each participant was offered both group and individual counseling over the two years of the study.

After six months, the people in the study had lost more than nine pounds of total body fat and five pounds of lean body mass on average, but after two years had regained some of this. Comparing all four of the diet groups, there was no difference in fat loss or muscle loss. Neither did the proportion of carbohydrate, fat, or protein affect the amount of abdominal, visceral, or liver fat lost. People were able to maintain a weight loss of nearly nine pounds at the two-year mark, including a nearly three-pound loss of abdominal fat.

According to Dr. George Bray, a researcher who worked on the study, the major predictor for weight loss was adherence. The people who adhered to their assigned diet lost more weight than those who did not.

Adherence was a problem in this study. Many of the study participants did not complete the study, and the diets of those who did stick with it weren't exactly what they were supposed to be. Researchers hoped to see two of the diet groups adhere to the average-protein diet (15 percent) and the other two groups stick with the high-protein diet (25 percent). However, all four groups ate about 20 percent of their calories from protein over the two years of the study.

The take home message from this study is that any "diet" can work if total calories are consistently reduced. People will be more successful at losing weight if they choose a healthy diet plan that is easy for them to adhere to for the long haul, and they stick with it.

A breakdown of the meal plans used for the four diets in this study can be located here.

The study was published online January 18, 2012, in the American Journal of Clinical Nutrition.

Image: italianestro/Shutterstock.

This article originally appeared on TheDoctorWillSeeYouNow.com, an Atlantic partner site.

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A Calorie Is a Calorie Is a Calorie: All Diets Work if You Stick to Them

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By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Vivus Inc.'s ( VVUS) obesity drug Qnexa was effective at helping people lose weight but raised concerns about possible long-term side effects such as birth defects and an unknown impact on the heart.

Qnexa is being reviewed by the FDA for a second time after previously being rejected by the agency in 2010. The agency posted a review of Qnexa to its website Friday in advance of an advisory panel meeting on Wednesday. The review of the drug includes two-year clinical data rather than one year's worth of data that was reviewed in 2010.

Qnexa will face the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts. The panel is being asked to vote on and discuss a series of questions including whether the "overall benefit-risk assessment" supports approval of Qnexa. The FDA usually follows the advice of its panels but isn't required to.

In 2010 the FDA rejected Qnexa and asked Vivus for an assessment of the drug's potential to cause birth defects and for evidence that the product doesn't increase the risk for major adverse cardiovascular events.

On Friday, the FDA said Qnexa resulted in "significant" weight loss after the first year of treatment with Qnexa, but noted that patients regained some weight in the second year of the studies. The agency also raised the same concerns as it did in 2010 about a small increase in heart rate and a risk of birth defects.

Other studies of one of Qnexa's ingredients topiramate have suggested an increased risk of birth defect. The FDA said exposure to topiramate in pregnancy "is likely to be associated with a two- to fivefold increased prevalence of oral clefts," a defect of the mouth that can be later treated with surgery.

Vivus initially proposed limiting use of the drug to men, as well as women of nonchild-bearing age. But Vivus said the FDA asked the company to develop a plan to limit use by pregnant women. Vivus, in a document also posted to the FDA's website, said Qnexa produces durable weight loss, which "can be expected to contribute greatly toward ameliorating some of the consequences of obesity and weight-related [illnesses]."

Qnexa is a controlled-release formulation that combines low doses of two older drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full. Topiramate is sold under the brand name Topamax by Johnson & Johnson (JNJ) to treat migraines and seizures.

The development of obesity compounds has been a tough area for companies since the fen-phen drug combination was taken off the U.S. market in 1997 after one of the medication's components was linked to heart-valve damage. Abbott Laboratories (ABT) removed its weight-loss drug Meridia from the U.S. market in 2010 amid concerns about the drug's risk of side effects like heart attack and stroke.

-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

(END) Dow Jones Newswires 02-17-120910ET Copyright (c) 2012 Dow Jones & Company, Inc.

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FDA: Vivus Weight Loss Drug Effective But Has Safety Concerns

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(Reuters) - Vivus Inc's obesity drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, U.S. drugs reviewers said.

Food and Drug Administration staff will ask an advisory panel to consider whether the drug's benefits for obese patients will outweigh its risk of birth defects and heart problems.

The FDA staff, in documents posted online on Friday, said patients taking Qnexa during a clinical trial lost more weight, and kept it off for longer, than patients taking a placebo, or sugar pill. These patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could get worse over time. They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

Shares of Vivus rose 2.4 percent to $11.45 in pre-market trading.

An advisory panel of outside experts will vote February 22 on whether to recommend the drug, and the FDA is due to make its final decision by April 17.

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October, proposing to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking the drug, in response to an FDA request.

(Reporting by Anna Yukhananov; Editing by Derek Caney and Steve Orlofsky)

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Vivus obesity drug has safety risks: FDA staff

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* Qnexa drug helped patients lose weight - FDA staff

* Vivus (Xetra: 893380 - news) shares up more than 5 pct

* Qnexa tied to heart, memory problems

* FDA staff say long-term safety with Qnexa unknown (Adds details from FDA review, context on obesity drugs)

Feb 17 (Reuters) - Vivus Inc's Qnexa helped people lose weight but may cause long-term health problems, U.S. drug reviewers said in their first assessment of an obesity drug after a series of high-profile rejections in recent years.

Food and Drug Administration staff will ask an advisory panel next week to consider whether Qnexa's benefits for obese patients outweigh its risk of birth defects and heart problems, or if the company needs to do more studies.

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.

But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug in 13 years.

The FDA rejected Qnexa in 2010 because of safety problems, and in documents posted online on Friday, still seemed skeptical about the drug's long-term health effects, especially on the heart.

"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said.

The FDA staff said they would ask an advisory panel on Wednesday whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision on the drug by April 17.

Shares of Vivus rose 5.2 percent to $11.76 in morning trading on Nasdaq (Nasdaq: ^NDX - news) .

FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

REAL-WORLD PROBLEMS

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

But in its review on Friday, the FDA staff said limiting the drug to nonpregnant women might be difficult in the real world, especially since 34 women managed to get pregnant during the clinical trial.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October with more data and proposed to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking it, in response to an FDA request.

Vivus is not the only company vying to get an obesity drug on the market.

Arena Pharmaceuticals (NasdaqGM: ARNA - news) and Orexigen Therapeutics have been pitching their own fat-fighters to the FDA, but like Vivus, have faced rejections.

In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug.

The FDA is also set to review Arena (Milan: ARE.MI - news) 's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.

Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.

Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.

The only prescription obesity drug approved for long-term use is Roche Holding AG's Xenical, which gained approval in 1999. GlaxoSmithKline (Other OTC: GLAXF.PK - news) markets a lower-dose, over-the-counter version called Alli. But both have their own problems, as they can cause serious liver problems, uncontrolled bowel movements and gas. (Reporting by Anna Yukhananov; Editing by Derek Caney, Steve Orlofsky and Lisa Von Ahn)

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UPDATE 2-Vivus obesity drug has safety risks-US FDA staff

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* Qnexa drug helped patients lose weight - FDA staff

* Vivus (Xetra: 893380 - news) shares up 3.4 pct

* Qnexa tied to heart, memory problems-FDA

* FDA staff say long-term safety with Qnexa unknown (Recasts lead, adds analyst comments)

Feb 17 (Reuters) - Hopes were raised slightly on Friday that U.S. health regulators could approve a weight-loss pill for the first time in 13 years, after government reviewers did not flag fresh safety risks for an experimental obesity drug from Vivus Inc.

Food and Drug Administration staff said in documents posted online that the drug Qnexa did help people lose weight, though they reiterated concerns about the risk of birth defects and heart problems.

The FDA rejected Qnexa in 2010 because of safety problems, and on Friday agency staff still seemed skeptical about the drug's long-term health effects, especially on the heart.

However, analysts found some upside in the fact that the FDA did not raise new safety concerns.

"Our initial take is that we are incrementally more positive on approval," said Cory Kasimov, analyst at JP Morgan, in a research note. "Overall, we see no major surprises."

Shares of Vivus rose 3.4 percent to $11.56 in early afternoon trading on Nasdaq (Nasdaq: ^NDX - news) , well above the stock's low around $4.70 after the pill was first rejected.

FDA staff will ask a panel of outside experts next Wednesday to consider whether the benefits of Qnexa for obese patients outweigh its safety risks, or if the company needs to do more studies.

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.

But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug since 1999.

Qnexa is one of three obesity pills up for a second round of consideration from the FDA.

"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said about Qnexa.

The FDA staff said they would also ask the advisers whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision by April 17.

FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

REAL-WORLD PROBLEMS

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

Vivus resubmitted its application to the FDA in October with more data and proposed to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking it, in response to an FDA request.

Jason Butler, an analyst at JMP Securities, said the FDA's request to allow non-pregnant women to take the drug was a positive sign.

"The FDA is saying ... it's a small signal of risk, but it's not so great that we have to stop people using it," Butler said, adding he expected heart issues to be a greater concern.

However, in its review on Friday, the FDA staff said limiting the drug to nonpregnant women might be difficult in the real world, especially since 34 women got pregnant during the clinical trial.

Vivus is not the only company vying to get an obesity drug on the market.

Arena Pharmaceuticals (NasdaqGM: ARNA - news) and Orexigen Therapeutics have been pitching their own fat-fighters again to the FDA after rejections.

In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug.

The FDA is also set to review Arena (Milan: ARE.MI - news) 's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.

Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.

Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.

The only prescription obesity drug currently approved for long-term use is Roche Holding AG's Xenical, which got the FDA's nod in 1999. GlaxoSmithKline (Other OTC: GLAXF.PK - news) markets a lower-dose, over-the-counter version called Alli. But both have their own problems, as they can cause serious liver problems, uncontrolled bowel movements and gas. (Reporting by Anna Yukhananov; Editing by Steve Orlofsky, Lisa Von Ahn and Tim Dobbyn)

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UPDATE 3-Modest hope for FDA approval of Vivus obesity drug

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(CBS/AP) An experimental diet pill from drugmaker Vivus Inc. has federal health officials concerned.

Vivus, based in Mountain View, Calif., plans to convince experts of the drug's safety next week. It hopes to bring the weight loss drug to market for the first time in more than a decade.

PICTURES - 6 weight-loss supplements to avoid

In the past two years, the Food and Drug Administration has rejected pills from all of the three small drugmakers with such offers: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Vivus' pill, Qnexa, in October 2010, with concerns about two particular safety issues: potential heart problems and birth defects in women who become pregnant while taking the drug. The agency plans to ask experts to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss increased blood pressure and higher heart rates reported for patients taking the drug.

The panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.

With U.S. obesity rates close to 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

Qnexa is a combination of two older drugs. The amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in studies - on average, 10 percent of total body mass.

But at Qnexa's first FDA panel in 2010, experts voted 10-6 against the drug. Panelists said the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

If Qnexa is approved, Vivus plans to offer a follow-up study to monitor patients for any heart problems. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug. One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is not widely used because of insignificant weight loss results.

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Vivus weight loss drug faces FDA concerns

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