16-02-2012 16:28 TayTay's 100lb Weight Loss Journey weigh in 20 and 21.

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SILVER SPRING, Md. — A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.

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The FDA panel of outside physicians voted 20-2 Wednesday in favor of the weight loss drug from Vivus Inc., setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.

A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected in April.

In a key question, the physicians said Vivus could conduct its study after FDA approval. Conducting the study ahead of market approval would cost the company millions of dollars and take at least three more years.

"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected the diet pill Qnexa in October 2010, citing numerous side effects including raised heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.

Vivus President Peter Tam said the overwhelming panel vote Wednesday underscores the need for effective weight loss drugs.

"I think they see the medical need," Tam said. "Right now there aren't any good treatments out there besides dieting and bariatric surgery, clearly there's a huge gap."

With U.S. obesity rates nearing 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. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.

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

Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa. One of the two ingredients in the combination pill, topiramate, is known to more than double the risk of birth defects.

There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.

If approved, FDA scientists said they would require Vivus to train prescribers in the pregnancy risks of Qnexa and distribute warning pamphlets to patients. The drug would only be available from 10 mail-order pharmacies. An experimental obesity drug from Vivus Inc won a U.S. panel's support on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.

A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 17.

© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Excerpt from:
FDA panel backs weight loss drug Qnexa

By Anna Edney - Wed Feb 22 22:13:35 GMT 2012

Vivus Inc. (VVUS)’s weight-loss pill Qnexa won the backing of a U.S. advisory panel as the company seeks to gain approval for the first new obesity drug in 13 years.

Advisers to the Food and Drug Administration voted 20-2 today that Qnexa’s benefits outweigh its risks at a meeting at agency headquarters in Silver Spring, Maryland. The FDA isn’t required to follow the panel’s recommendation. The agency is scheduled to make a decision on the drug, which it rejected in 2010, by April 17.

Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drugmaker Roche Holding AG (ROG)’s Xenical in 1999. The FDA plans to have advisers discuss in March the possibility of requiring heart-risk studies for all weight-loss drugs. Panel members discussed whether Vivus should conduct such a study before or after approval.

“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” said Sanjay Kaul, a cardiology professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member.

Regulators raised concerns that Qnexa may contribute to a greater risk of heart ailments and birth defects. The medicine combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug. The Mountain View, California- based company has proposed a post-approval trial to assess Qnexa in reducing major heart complications in obese, at-risk patients. The trial would involve 11,300 patients and take four and a-half years.

Sales Potential

Analysts say the drug, if approved, may generate $448 million in sales in 2015.

Topiramate is the active ingredient in Johnson & Johnson (JNJ)’s Topamax. The anticonvulsant is also associated with confusion, difficulty with concentration and memory loss.

Vivus’ analysis of heart risks for Qnexa was “somewhat reassuring,” though the significance of an observed increase in heart rate was “uncertain,” FDA staff said Feb. 17 in a report.

More than one-third of U.S. adults are obese, and another third are overweight, according to the Centers for Disease Control and Prevention. The obesity rate among adults has more than doubled since 1980 to 72 million people.

Obesity Risks

Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.

Orexigen Therapeutics Inc. (OREX), based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. (ARNA) also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.

Vivus examined medical claims data and found five oral clefts in a group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent, the company said Dec. 21 in a statement. That compared with a rate of 0.16 percent in the group whose mothers had taken antiseizure drugs, including topiramate, before pregnancy.

Vivus plans to finish the results in the third quarter of this year, after the April 17 deadline for the FDA to decide whether to approve the drug. The risk of oral clefts hasn’t been fully answered by the interim data, FDA staff said.

Topiramate Effects

The FDA asked Vivus in January to remove wording from Qnexa’s proposed prescribing label advising women with the potential to become pregnant against taking it. The FDA staff said in the Feb. 17 report severely restricting Qnexa isn’t practical because topiramate also treats other serious conditions.

Panel members suggested the FDA should consider restricting topiramate used for seizures and migraines for women of childbearing age.

“I just can’t get my mind around why it would be different,” said Lamont Weide, chief of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a member of the panel.

Russell Katz, director of FDA’s neurology products division, said the agency hasn’t considered restricting the drug because there aren’t many options for migraine prevention.

Vivus has suggested restricting distribution of Qnexa to less than 10 large mail-order pharmacies with pharmacists trained in dispensing the drug, Barbara Troupin, senior director of global medical affairs at the company, said.

In addition to Roche’s Xenical, London-based GlaxoSmithKline Plc (GSK)’s Alli, a half-dose version of Xenical’s active ingredient, won FDA clearance in 2007 as the first diet drug available without a prescription.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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Vivus Weight-Loss Pill Qnexa Wins Backing of FDA Advisory Panel

WEDNESDAY, Feb. 22 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel gave its endorsement Wednesday to a highly anticipated weight-loss pill that had been rejected by the health advisers once before.

The committee of outside physicians voted 20-2 to back the drug Qnexa, although the group urged that patients be monitored closely for potential heart problems, the Associated Press reported.

A decision by the full FDA is expected in April. The agency typically follows the recommendations of its advisory panels.

While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. Before making its decision Wednesday, the advisory panel reviewed two years of data on the drug; when advisers last voted on Qnexa, only one year's worth of follow-up data was available.

The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of the combination, not the phentermine.

No new weight-loss drug has been approved in the United States in the past 13 years, according to published reports. As it stands, Xenical is the only FDA-approved drug specifically for long-term use -- up to a year -- for weight loss. Xenical is sold over-the-counter as Alli. However, other drugs may be used off label to promote weight loss.

Last April, a study funded by Vivus found that obese patients taking Qnexa lost an average 22 pounds over a year, while also lowering their blood pressure and cholesterol levels.

Dr. Louis Aronne, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, was cautiously optimistic that Vivus did a good job responding to FDA safety concerns, and that the FDA will give the drug its nod of approval, with some caveats. Aronne was not involved in the trials but has been an adviser to Vivus and other companies developing weight loss medications.

"I am not as pessimistic as most people," he said.

Vivus has reported that Qnexa may increase the risk of cleft lip in babies of women who use the drug while pregnant. Aronne said the birth defect concern could be addressed through education on who should and should not use the new drug.

"We have learned our lessons with weight loss drugs," he said. "They need to be used in the right people under the right circumstances." The heart risks need to be weighed against reductions in heart disease risk factors that come with weight loss, he said.

Qnexa is not any riskier than bariatric surgery, according to Aronne. "The problem is that it can be distributed more widely," he said. He hopes for a compromise that allows the new compound to be prescribed, but not misused. "Once new medications are approved, local medical boards will need to enforce rules and make sure these medications are prescribed appropriately to the right candidates," he said. "We don't want to open up pill mills."

One thing is clear, he said: More options to treat obesity are needed. "For hypertension, there are 120 medications in nine categories," Aronne said. "We need new options and we need to get physicians thinking about obesity and obesity treatments."

Dr. Scott Kahan, an obesity expert at Johns Hopkins University in Baltimore and director of the National Center for Weight and Wellness in Washington, D.C., agreed. He is optimistic about the FDA's upcoming decision on Qnexa. "The weight loss effects are striking and approaching the amount of weight loss over two years that we get with bariatric surgery," he said. "This is really impressive."

More information

Learn more about weight loss medications at the U.S. National Institutes of Health.

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FDA Advisers Back Weight-Loss Drug Qnexa

Healthhound.org releases their quick weight loss video. The new video has been well received by people on the site.

Houston, TX. (PRWEB) February 22, 2012

Healthhound.org has just released a quick weight loss video for their readers. The video is available on the site right now for people who are interested in losing weight quickly.

Rachel Delaney, one of the Directors on the site said that “this is one of the best videos that we have released in years. We have compressed all the knowledge that we have accumulated on quick weight loss into 2 hours of high quality footage of diet and exercise techniques. We believe that people will especially benefit from the exercise portion of the video as it shows one exactly what to do on video if one wants to lose weight quickly. We are always getting requests from our readers on the site looking for us to make a video about quick weight loss methods so we are very happy to have finally produced one for our readers. We are looking forward to seeing some quick weight loss stories from our readers coming in on the site in the next few weeks”.

The news of the new video has been spreading to a number of sites online that are connected to the fitness and wellness industry and many of the people who frequent these sites have been busy commenting on the new video. Many of the commentators are remarking on how they think the video is really good value and other commentators are saying how pleased they are to see a video come along like this as opposed to just another report.

In addition to the new quick weight loss video the team on the site have also come up with a new report this week on quick and easy ways to lose weight.

The new report is free to download and can be accessed right now at http://www.healthhound.org/3213/quick-weight-loss/.

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Jose C. Boyd
healthhound.org
978-874-6879
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Healthhound.org Releases Their Quick Weight Loss Video

With the holidays behind us and swimsuit season fast approaching our minds and attention go to weight loss. The focus of losing weight should mean being healthy not being skinny. Being overweight puts you at risk for heart disease, high cholesterol, high blood pressure, diabetes, cancer and back problems.

You want to stop thinking about dieting and start thinking about being healthy. You need to eat to be healthy, not "diet" to be thin. Beware of any diet that is very low in calories and omits a whole food group promising quick weight loss, which is illusionary with the first 5 lbs. coming from water loss... this is surly a "fad diet." So if you are on a "fad diet" ask yourself if you can do this forever. Most likely your answer is no. So start eating to be healthy. The idea of a "diet" has a beginning and an end. You have to start thinking about your life style and that you need to eat healthier forever.

Body weight is about energy balance, and calorie is another word for energy. So to maintain your weight calories in must equal calories out. To lose weight, calories in must be less than calories out, which eating less and exercising more can do.

We get calories from the food that we eat in the form of proteins, fats and carbohydrates. Fat gives us the most calories; therefore if we cut the fats we will be taking in fewer calories. Saturated fats, which are solid at room temperature, are directly related to heart disease and raise the artery clogging bad cholesterol, LDL. Therefore avoid butter, bacon, sour cream and whipped cream, fat in red meat, whole milk. Instead focus on monounsaturated fats like olive oil, canola oil, avocados and most nuts, which lower LDL cholesterol.

Portion control is another way to reduce calories. How much are you eating? Too much of a good thing will also make you gain body fat. Twelve almonds are 100 calories and your average bagel is equivalent to six slices of bread. So portion size is key.

Exercise is how we burn those calories going out. It is recommended that you exercise five times a week for a minimum of 30 min. Aerobic exercise like running, swimming and walking burns fat but only after 20 minutes in your target heart rate zone. Anaerobic exercise like weight training builds muscles, which increase your metabolism. Therefore it is important to do a combination of both types of exercise.

If you eat to be healthy, the bonus is you will be thinner.

To learn more on how to eat to be healthier and lose weight join "Transformations," an eight-week weight loss program at Norwalk Hospital. New classes start Tuesday, March 13 at 12 p.m. and Thursday, March 15 at 5:30 p.m.. Call Cindy Allen at 203-855-3548, or 203-852-2178 to register.

Schmidt is a nutrition lifestyle specialist at Norwalk Hospital.

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Hospital's weight loss program begins in March

Cheesesteak Franchise CEO Tony Luke, Jr. Dropped 125 Pounds With Help of Weight-Loss Expert Dr. Matthew Pinto

Tarrytown, New York (PRWEB) February 22, 2012

The Center for Medical Weight Loss, the largest network of non-surgical medical weight loss providers in the US, today announced a partnership with Philadelphia’s Cheesesteak King Tony Luke, Jr., who lost more than 125 pounds with the help of one of its member physicians. Together they will work to make people aware of the benefits of turning to a medical professional to lose weight, and to maintain weight loss.

Through an individualized diet plan and one-on-one support from Dr. Matthew Pinto of Bellmawr and Marlton, New Jersey, Luke was able to lose over 125 pounds by changing his life to practice proper portion control as well as implementing an effective exercise plan, all while still continuing to eat his beloved cheesesteaks.

“Tony is a guy whose life depended on changing the way he viewed food – he often used to eat 20 egg whites for breakfast and follow it up with three cheesesteaks for lunch,” said Dr. Pinto, a former CMWL patient himself. “By stressing the importance of reasonable portion sizes and regular exercise, Tony was able to lose weight steadily over the last year and still enjoy his favorite foods in moderation.”

CMWL offers individuals who have previously had trouble losing weight a proven, evidence-based alternative, providing a physician-supervised program and focusing on a comprehensive, holistic approach that includes diet, exercise and behavioral modification.

“Dr. Pinto tracked other aspects of my overall health and customized the program to allow me to attack my weight in phases,” said Luke. “I am looking forward to losing the last 25 with his guidance and then moving into maintenance.”

Tony Luke, Jr.’s success story will appear on CMWL’s website as well as in an online video. Luke will also share his story through public appearances and social media.

"We commend Tony on making the lifestyle changes necessary to dramatically improve his health, which certainly isn’t easy for someone who makes a living in the restaurant business,” said Dr. Michael Kaplan, CMWL’s founder and chief medical officer. “Tony proves to us all that it is entirely possible to fight the disease of obesity in a non-surgical way.”

About Center for Medical Weight Loss

The Center for Medical Weight Loss (CMWL) programs provide an approach to long-term weight loss and maintenance under the care and support of trained physicians. Each fully individualized program is customized to the patient, taking into account his or her medical history, body composition, and personal goals. This individual care is supported with on-going one-on-one counseling by the physician on important topics including nutrition, fitness, behavioral modification, motivation, and, where necessary, prescribed medications. Physicians in The Center for Medical Weight Loss network are all certified professionals specially trained in non-surgical bariatric medicine who have access to the latest techniques and medical data, including high-quality nutritional products and FDA-approved weight loss medications only available to medical doctors. The CMWL programs are clinically proven and evidence-based. For more information, visit http://www.centerformedicalweightloss.com.

About Matthew Pinto, D.O.

Matthew Pinto is a physician with extensive training in medical weight loss who understands that it is a very personal process. After extensive training, he opened The Center for Medical Weight Loss of South Jersey in July 2010 and expanded the practice to a second location in May of 2011. He has a third location in the works. Pinto graduated from the Philadelphia College of Osteopathic Medicine in 2000.

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Ariel Abramowitz
Rose Communications
201-656-7178
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Philly Cheesesteak King Downsizes With the Center for Medical Weight Loss

HCG's effectiveness as a fat burner has been thoroughly documented, but can it stimulate fast weight loss by spring? With the spring season just around the corner, the last few days have brought an inflow of comments and emails from visitors wanting to know if hCG drops and hCG injections can promote fat loss by the start of spring. Responding to this query, hCG Blog reveals that taking hCG drops or injections in conjunction with the hCG diet can help dieters lose a significant amount of weight before the middle of March.

(PRWEB) February 22, 2012

As the weather starts to heat up and winter comes to an end, individuals are trading in their coats, scarfs and pants for less concealing, more revealing items of clothing – a change that prompts many people to suddenly become concerned about their weight. With spring quickly approaching, many hCG Blog visitors over the last few days have commented and emailed in wondering if hCG is powerful enough to help them lose weight by spring. HCG Blog explains that by combining the hCG weight loss diet with either hCG drops or injections, users can lose 1-2 pounds per day – this means that significant weight loss by mid-March is possible.

"By following the hCG diet and taking hCG drops, users report losing an average of one to two pounds per day," says Wendy Miles, founder of hCGBlog.com. "And with nearly four weeks until the start of spring – dieters can drastically decrease the size of their waistlines in time for warmer weather and skin-bearing garments. HCG is the best choice for any individual trying to lose weight quickly and easily."

While weight loss results of this magnitude seem too good to be true, the science behind hCG demonstrates that losing a considerable amount of weight with hCG is possible in a short period of time. HCG Blog explains, however, that attempting the hCG diet without taking hCG drops or injections is extremely dangerous. The diet alone will not promote fast weight loss – if one was to try this 500 calorie diet without taking hCG, his metabolism would shut down and enter into ketosis.

For more information about the hCG diet and how hCG works, please visit hCGBlog.com.

Editor's Notes: hCGBlog.com was founded to help provide answers and support for both those on the hCG diet and others who are simply interested in learning about weight loss with hCG.

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Wendy Miles
hCG Blog
1-800-365-1129
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Can hCG Drops Help Users Lose Weight by Spring?