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Entries in Qnexa (6)

Tuesday
Jul172012

FDA Approves Weight Loss Drug Qnexa

Lauren Nicole /Digital Vision(WASHINGTON) -- The U.S. Food and Drug Administration (FDA) has approved the diet drug Qnexa, the agency's latest move to give doctors and their patients more tools to fight excessive weight gain as obesity rates continue to bulge in the U.S. and around the world.

An advisory panel in February had voted 20 to two in support of Qnexa. The FDA's decision Tuesday marks the first time the agency is consenting to a weight-loss drug in more than a decade. Data presented by Vivus, Qnexa's manufacturer, showed that it helped patients lose about 10 percent of their body weight.

The committee's recommendations and Tuesday's approval by the FDA drew both praise and criticism, reflecting concern over the drug's side effects as well as the need to give patients more choices beyond diet, exercise and bariatric surgery.

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"Considering the heavy toll of obesity in our society, this agent has tremendous potential," said Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Medical Center in New Orleans.

"I do think it will help a subpopulation lose weight. However, I am concerned that mass marketing of this drug will perpetuate the magic bullet approach to weight loss, which is limiting and does not address the root problem," said Dr. Gerard Mullin, an associate professor at Johns Hopkins School of Medicine.

About one-third of Americans are obese, and many have chronic, expensive medical conditions as a result, such as heart disease, diabetes and arthritis. Until recently, the array of available medical options has been frustratingly sparse for many doctors and their obese patients: diet, exercise and, for those overweight enough to qualify, bariatric surgery.

"I think it's clear from current research that there are problems with weight-regulating mechanisms in the brain that make it difficult for people to lose and maintain weight," said Dr. Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital. "We need to come to that realization that we're better off treating people who are obese than blaming them."

Qnexa is a combination of two FDA-approved drugs: phentermine, a stimulant related to the amphetamines that suppresses the appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight-loss side effects. Vivus emphasizes that the drug is intended to be used in combination with diet and exercise.

In June, the FDA approved another diet drug, lorcaserin or Belviq. The drug is also an appetite suppressant and intended for patients who are obese and have one additional weight-related health problem, such as high blood pressure, type 2 diabetes or high cholesterol. However, studies of Belviq found that patients lost about four percent of their body weight, compared with the 10 or 12 percent lost by Qnexa patients.

But Qnexa is not without drawbacks. When Qnexa's manufacturer, Vivus, initially submitted the drug for approval in 2010, the FDA voted it down, citing concerns over the potential for dangerous heart problems, birth defects and cognitive effects such as mental fogginess or lack of concentration in patients taking the drug.

The 2012 panel voted to approve the drug only with Vivus' assurances that the company would provide detailed information to physicians about the risks of the drug and how to manage them.

Still, doctors are mixed in their concern over the potential for side effects, particularly in light of the history of diet drugs, such as fen-phen, approved by the FDA, then withdrawn from the market over concerns about heart risks and other dangerous side effects.

"Honestly, I won't be surprised if adverse effects over time result in a reversal of the approval," said Dr. David Katz, director of the Yale Prevention Research Center. "But in the interim, it will help some people lose weight, and many others will try it, dislike it and stop, and gain the weight back."

Evans said she's gained about 20 pounds since she stopped taking Qnexa in 2009. She said the gain is due in part to an injury to her Achilles tendon that has kept her from being as active as she was. But she said she would definitely consider taking it again to help her bring her weight down.

"Just to know that it's available if I need it, that's a real nice little prize," she said.

Copyright 2012 ABC News Radio

Thursday
Feb232012

Qnexa Ruling Renews Debate About Its Risks and Benefits

FDA/iStockphoto/Thinkstock(WASHINGTON) -- The decision by a federal advisory panel to recommend Qnexa for approval by the U.S. Food and Drug Administration is drawing praise and criticism from obesity and diet experts, reflecting a still-hot debate on the need for additional tools to treat obesity.

The 20-2 decision recommending approval Wednesday came as a surprise to many experts. The FDA has not approved a weight-loss drug in the past 13 years and has withdrawn from the market many drugs due to concerns over heart risks and other side effects.

Qnexa was rejected by the agency in 2010 after a 10-6 vote against approval by the same panel, which included about half of the same members as Wednesday's.

But the panel this week agreed that the health risks of obesity and the benefits of losing weight outweighed the risks posed by the drug.

"The approval of Qnexa is a major step forward for the field of obesity treatment and is the result of advances in our understanding of the health consequences of obesity, and the resistance mechanisms that make it difficult to lose weight," said Dr. Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital.

Qnexa's rejection in 2010 was largely due to concerns over the potential for heart problems, birth defects and mental effects such as lack of concentration and fogginess for patients taking the drug.

The panel seemed to be moved this time by plans by the drug's manufacturer, Vivus, to minimize those risks through measures like labeling and an additional trial to investigate cardiovascular side effects.

But some experts say the side effects are still a major concern for a drug that will likely be sought by millions of people.

"This is far from a great drug," said Dr. David Katz, director of the Yale Prevention Research Center. "The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that...desperation."

One-third of Americans are obese and have chronic, expensive health problems as a result -- diabetes, heart disease and arthritis, to name a few. Patients and doctors are often frustrated by the lack of middle-ground options between traditional recommendations for diet and exercise and the more extreme approach of bariatric surgery.

Patients and doctors aren't the only ones antsy for a solution. The FDA has faced mounting pressures from health care groups and patient advocacy organizations to take obesity more seriously as a condition worthy of pharmacological treatment. In a letter in September, the U.S. Senate Appropriations Committee directed the FDA to file a report by March 30, 2012 on the steps it will take to "support the development of new treatments for obesity."

Critics say the search for an anti-obesity drug is nothing more than a search for a "magic bullet" cure for obesity to eliminate the need for making difficult lifestyle changes.

"The approval of Qnexa feeds into a quick-fix approach to weight management," said Dr. Gerard Mullin, associate professor at Johns Hopkins School of Medicine. "The solution to the overweight-obesity epidemic lies not in another effortless 'quick fix' but in a painful but permanent lifestyle solution."

Qnexa is a combination of two drugs already approved by the FDA: phentermine, a stimulant that suppresses appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight loss as a side effect. Vivus recommends that the drug be prescribed as a part of weight loss plans that include diet and exercise.

Clinical trials so far show that the drug helps people shed 10 percent of their body weight, although patients regained some weight in the second year on the drug. It also seemed to have positive effects on blood sugar and blood pressure.

The FDA will decide whether or not to approve Qnexa by April 17. Although the agency usually follows the recommendations of its panels, the drug's fate is not assured. In 2011, a panel recommended the weight loss drug Contrave for approval, but the FDA declined to follow its advice.

Copyright 2012 ABC News Radio

Wednesday
Feb222012

FDA Panel Recommends Approval of Diet Drug Qnexa

FDA/iStockphoto/Thinkstock(WASHINGTON) -- A U.S. Food and Drug Administration Advisory Committee Wednesday recommended approval of the weight loss drug Qnexa, a treatment many hope will help millions of Americans who struggle with obesity.

In voting 20-2 for approval, the committee said Wednesday that Qnexa’s weight-loss benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug’s side effects, and the FDA rejected it shortly after that. Vivus, the drug’s manufacturer, recently submitted additional research.

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The committee Wednesday recommended that the manufacturer take a number of steps to prevent the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years.

The FDA has considered numerous anti-obesity drugs in the past 20 years, but most have failed to meet the agency’s standards for safety and effectiveness. But so far, data on Qnexa suggests that the drug is the most effective in helping patients shed up to 10 percent of their body weight. Those changes, along with diet and exercise modifications, could go a long way toward alleviating some of the health problems associated with obesity, such as diabetes and high blood pressure.

Critics say the risk of potentially dangerous side effects of Qnexa, which include increased heart rate, heart attacks and arrhythmias, are too great to make the drug available to millions of people, especially because long-term effects of the drug are still largely unknown.

“Public health cannot tolerate another diet drug approved that has not been accepted for cardiovascular risk especially in light of the suggested findings of Qnexa,” said Dr. Sidney Wolfe, director of the health research group at Public Citizen, an advocacy group.

Obesity currently plagues one-third of Americans and has been linked to high blood pressure, diabetes and a range of other chronic, expensive health problems. Doctors and dietitians routinely recommend changes in diet and exercise as the safest and most effective way to shed pounds. But some acknowledge that these strategies just don’t work for a large number of obese patients. Bariatric surgery, though largely successful in producing weight loss, is not a viable option for many people.

Dr. Melina Jampolis, an obesity specialist in San Francisco, said the current options for treating obesity are “frustratingly limited,” and said it would be helpful if patients had additional tools to aid their weight loss.

“I think that combination therapy is essential as there are numerous individual and overlapping mechanisms that make weight loss difficult,” she said. “So the more of them that you can address with medication therapy when necessary, the more effective a regimen will be.”

Copyright 2012 ABC News Radio

Friday
Feb172012

FDA to Reconsider Once-Rejected Diet Drug

Comstock/Thinkstock(WASHINGTON) -- In the search for treatments to fight obesity, regulators have turned their attention to a diet drug that has already failed to receive government approval as a weight-loss treatment.

Next week, a panel of advisers to the U.S. Food and Drug Administration will consider whether to recommend the diet drug Qnexa for approval as a weight loss drug. The move is the latest effort in the battle against obesity, which currently plagues one-third of Americans.

Qnexa was rejected by the FDA in 2010 over concerns about its potentially dangerous side effects, such as cardiovascular problems and birth defects. Now  the FDA will again weigh in on whether the drug’s manufacturer, Vivus, should do a larger trial to investigate the potential for cardiovascular side effects.

But some obesity specialists are in effect already getting the drug to their patients by prescribing Qnexa’s two major ingredients, phentermine and topiramate. The practice, called off-label prescribing, is not prohibited by the FDA. Doctors who have prescribed this combination say it has helped patients shed pounds when many other paths to weight loss had failed.

Dr. Jana Klauer, a New York City doctor specializing in weight management, said her patients lose an average of 40 pounds when taking the drugs, along with improved diet and exercise.

“The drug combination gives great results, providing diet and exercise are part of the plan,” Klauer said.

Both phentermine and topiramate are FDA-approved for other uses, but come with their fair share of side effects. Topiramate can create feelings of mental fogginess, memory lapses and a lack of concentration. Phentermine, one of the drugs that made up the failed Fen-Phen, can lead to a range of cardiovascular side effects, such as high blood pressure, heart attacks and heart palpitations.

Dr. Charles Clark, a professor of pharmacology and toxicology at Indiana University, said the laundry list of potential side effects is enough to keep him from prescribing the drug to his patients, particularly in  light of Fen-Phen, which was withdrawn from the market in 1997 after causing fatal blood pressure and heart valve problems in patients.

Others say worries about side effects of both drugs and their offspring Qnexa are legitimate but could be managed or avoided if doctors carefully monitor their patients while they’re taking the drug. For example, the FDA’s concerns about potential birth defects associated wtih Qnexa could be resolved by not prescribing the drug to women who could get pregnant. Many doctors say the risks of these drugs may be outweighed by the benefits for some patients with failing health brought on by obesity.

Experts often promote the simple combination of diet and exercise as the safest, most effective way to lose weight. But many also recognize that these methods are largely unsuccessful for certain patients.

“The options we have now are few and mostly ineffective,” Clark said. “As much as I hate to admit it, the only effective option for the chronically morbidly obese patient with other risk factors is bariatric surgery that is not likely to be a universally accepted solution.”

Even physicians who don’t prescribe the drugs say they hope the FDA would approve Qnexa, giving another option to desperate patients and frustrated doctors who have few tools to fight the condition.

“Considering the dismal results that many experience with attempted weight loss with diet and exercise, which is always the first choice, and the explosion in the need and use of bariatric surgery, this combination drug should be a major advance, and I hope that it gets approved this time by the FDA,” said Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Clinic Foundation in New Orleans.

Copyright 2012 ABC News Radio

Monday
Apr112011

Weight Loss Drugmaker Vivus in Talks with FDA for Approval

Brand X Pictures/Thinkstock(DURHAM, N.C.) -- Despite promising results in clinical trials, the Food and Drug Administration has denied to approve several weight loss drugs over the years, further limiting people's resources in fighting obesity and weight gain.

One such disapproved drug is Qnexa -- an experimental weight loss drug that combines phentermine with topiramate, a drug approved for epilepsy and migraine prevention.

In a clinical trial at North Carolina's Duke University, 995 patients who received Qnexa in the phase three trial averaged a weight loss of 9.8 percent, compared to 1.2 percent among 994 patients who received a placebo.  The trial findings were published April 9 in The Lancet.

But despite the noted effectiveness, the FDA rejected an application from drug maker Vivus to have Qnexa approved for the treatment of obesity, citing safety concerns.  Qnexa was associated with a low but increased risk of psychiatric and cardiovascular adverse events.

"As clinicians and clinical researchers, we'd all consent that the FDA seem to have set a very different safety bar for drugs that treat weight loss compared to drugs that treat other conditions," said Dr. Kishore Gadde, director of Duke's obesity clinical trials program and lead author of the study.

Qnexa was one of three weight loss drugs nixed by the FDA in 2010.

"We need more options to treat obesity," Gadde said.  "In hypertension, you have about 40 to 50 drugs with different mechanisms.  In obesity, when you try diet and exercise and it doesn't work, you only have one drug before you jump to last resort, which is surgery."

The single drug approved for the treatment of obesity -- orlistat (Xenical or Alli) -- acts by preventing the absorption of dietary fat.  But it doesn't quash hunger.

"People know they should cut down on calories.  But if you only have orlistat, how do you deal with a patient who comes to you and says, 'I know all this stuff but I cannot control my hunger?'  For that patient orlistat won't work," Gadde said.

Vivus is in talks with the FDA to address any outstanding safety concerns, according to company president Peter Tam.

Gadde and Tam said they think the FDA is being hard on weight loss drugs because of the number of Americans who would use them.

Copyright 2011 ABC News Radio

Friday
Oct292010

FDA Closes the Door on Another Diet Pill

Courtesy - Getty Images(WASHINGTON) -- The Food and Drug Administration has rejected another diet pill.  This one, Qnexa, is the third one the panel has turned down this month. 

The FDA wasn't expected to approve the medication because a panel of outside experts voted in 10-6 in July against recommending approval for the combination drug -- made by Vivus -- which was shown in the company's clinical trials to be effective in helping obese and overweight patients lose an average of 6-10 percent of their body weight.

At the meeting, one panelist said the drug is "far superior to anything on the market." However, concerns over psychiatric and cardiovascular issues uncovered in the company's trials ultimately trumped the weight-loss benefit.

Copyright 2010 ABC News Radio







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