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30.03.2016
FDA clears first new weight-loss pill in 13 years A  The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments. The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The FDA said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.
Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the idea that lifestyle changes alone are not enough to treat obesity. Even if the effects of Belviq are subtle, experts say it could be an important first step in a new line of treatments that attack the underlying causes of obesity.
Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects. Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. Arena's studies showed that patients taking Belviq, known generically as lorcaserin, had modest weight loss. The FDA said patients should stop taking Belviq after three months if they fail to lose 5 percent of their body weight. Experts say the challenge of weight loss drug development lies in safely turning off one of the body's fundamental directives: to eat enough food to maintain its current weight. While several drugs are available for short-term weight loss, until Wednesday there was only one FDA-approved prescription drug for long-term weight loss: Xenical from Roche, which is seldom prescribed because of unpleasant digestive side effects and modest weight loss. Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. A new weight loss pill has been approved by the FDA and will be available by prescription in 2013.
The pill will be available to those who are classified as obese, those who have a BMI over 30 .
The drug’s makers, Arena Pharmaceuticals, tried and failed  to get the drug approved by the FDA in 2010. However, ABC News stated, “New studies by Arena Pharmaceuticals found no increased risk of heart valve problems and only a small risk of cancer. Qsymia, the first new prescription weight-loss drug to reach the market in 13 years is having a hard time winning even a tiny slice of that huge market, despite an apparent need. North Americans spend tens of billions of dollars each year to lose weight — gym memberships, Weight Watchers and other programs, operations, nutritional supplements and whatever the latest diet fad might be. But the first new prescription weight-loss drug to reach the market in 13 years is having a hard time winning even a tiny slice of that huge market, despite an apparent need.
Sales of the drug, Qsymia (pronounced Kyoo-sim-EE-ah), have been minuscule since it went on sale in September. More than a corporate drama, however, the slow start of Qsymia raises questions about what role prescription drugs really can play in combating the U.S. While there are some problems unique to Qsymia, it is also facing barriers that are likely to confront other weight-loss drugs as well, including Belviq, a drug from Arena Pharmaceuticals and Eisai, that went on sale last month.
These obstacles include lack of insurance reimbursement, modest weight loss, safety concerns, the troubled history of diet drugs, and a feeling on the part of many doctors and obese people themselves that excess weight is a lifestyle issue best addressed by more willpower, rather than a disease that requires medical treatment. Given that one-third of American adults are obese and another third merely overweight, an effective and safe diet pill would seem like the path to instant riches.
Yet no prescription drug for obesity has ever reached annual sales of even $1 billion, the lower boundary of what the pharmaceutical industry considers a blockbuster. While it is estimated that more than 2 million people take weight-loss drugs, the vast majority using the old generic appetite suppressor phentermine, that is still only a tiny fraction of the 70 million or more obese adults. Vivus said Monday that Qsymia was now available through 8,000 retail drugstores in the United States, removing a major barrier to sales.
The drug companies and other backers of the drug make the case that since obesity contributes to numerous other ailments like diabetes and heart disease, use of the pills to lower weight might actually produce a net savings for insurers, patients and Medicare. Because of the cost and cumbersome distribution system, when Qsymia first went on sale, as many as 30 per cent of the prescriptions were abandoned before being filled. To counter that, Vivus is offering the first two weeks of Qsymia free and is limiting out of pocket costs to $75 for the next month.
Vivus executives say they planned to target mainly endocrinologists first, but are now talking with larger pharmaceutical companies.
Meantime, the company says its strategy is falling into place, with retail pharmacies coming on line and organizations like the Veterans Health Administration and pharmacy benefits manager Express Scripts agreeing to pay for the drug.
Qsymia had been prescribed by 15,000 doctors to 40,000 patients as of the end of March, the company says, but prescriptions have risen since then. A new prescription weight loss drug has failed to win the support of advisers working on behalf of the US Food and Drug Administration.Citing an imbalance between benefits and risks, the FDA advisors said that Qnexa – which is manufactured by Vivus Inc.
Qnexa is among a trio of new weight loss drug medications currently seeking a gateway into the marketplace (the others are produced by Orexigen and Arena).While the FDA panel emphasised the prospect of side effects, they still praised the drug’s performance. In comments made on 15 July 2010 – the same day that the FDA panel gave its verdict on the drug – Vivus CEO Leland Wilson, stressed that the firm would collaborate with the administration in coming weeks, pending the hoped-for FDA approval.“While the final vote was close, and we are encouraged that the committee recognized the efficacy demonstrated in the Qnexa clinical trials, we will work closely with the FDA leading up to our October 28, 2010 date to address the labeling and safety questions raised during today's proceedings”, Wilson said. The views and opinions expressed here are that of the individuals and are in no way related to Copybook Ltd.
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Source Bioscience has acquired Stirling based experts in GMP pharmaceutical chemical analysis Select Pharma Laboratories Ltd. Contrave is an investigational medication being evaluated for weight loss and maintenance of weight loss.
WEDNESDAY, July 1, 2015 (HealthDay News) -- The injectable drug Saxenda may be a helpful tool in the battle against excess weight and obesity, a new study suggests. People who injected Saxenda (liraglutide) every day for a year lost an average of 18.5 pounds, compared with an average of 6 pounds for those taking a placebo, researchers found. Saxenda "can lower weight, improve cardiovascular risk factors and improve quality of life," said lead researcher Dr.
For the study, funded by the maker of Saxenda, Novo Nordisk, researchers recruited more than 3,700 overweight or obese people without diabetes .
Sixty-three percent of patients taking Saxenda lost at least 5 percent of their initial body weight, and one-third lost more than 10 percent of body weight, the researchers found. Losing 5 percent of body weight -- 14 pounds for someone at 280 -- can have a significant positive effect on the risk for diabetes and heart disease, Pi-Sunyer said. In the United States, more than two-thirds of adults are overweight or obese, according to a recent study in JAMA Internal Medicine.
Other drugs approved for weight loss in the United States include Orlistat (Xenical), lorcaserin (Belviq), phentermine-topiramate (Qsymia) and naltrexone-bupropion (Contrave). Although covered by most of the insurance plans and Medicare, "it has a high co-pay of $20 to $100, as it is not generic," Zonszein said.
The unanswered question about Saxenda is whether people can maintain their weight loss over time, especially when the medication is discontinued, said Siraj, co-author of an editorial accompanying the study.
A new weight loss drug was approved by the FDA to be issued to obese people in conjunction with a low-calorie diet and exercise. Before approving the drug Tuesday, the FDA evaluated Saxenda in three clinical trials that involved about 4,800 obese and overweight patients with and without significant weight-related conditions. The drug was only approved for obese adults with a body mass index (BMI) of 30 or greater, according the news release. The drug works by mimicking GLP-1 (glucagon-like peptide), which is a hormone made in the intestines, William Troy Donahoo, a staff physician in the Metabolic-Surgical Weight Management Department, Kaiser Permanente, Denver, said to WebMD.
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We Millennials are killing the art of conversation and the desire to make our voices heard a€“ really heard a€“ one text message at a time. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA. On the other hand, it's not the answer to the problem - or even a big part of the answer," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq.
But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr.
Belviq is the first new prescription drug approved to treat obesity since Xenical's approval 13 years ago.
In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. At the time, the FDA cited heart-valvue and brain and breast tumor development in lab rats that were given the drug. And people taking Belviq were twice as likely to have neuropsychiatric and cognitive side effects,” ABC News reported. Barbara Troupin, vice president for scientific communications and risk management at Vivus. Last month, the American Medical Association, the United States’ largest group of doctors, declared obesity a disease. Jack Lief, chief executive of Arena Pharmaceuticals, said in 2009 that sales of obesity drugs could eclipse those of statins, the cholesterol-lowering pills like Pfizer’s Lipitor, which had peak annual sales of about $13 billion before falling to generic competition.
An analysis of prescription data by the Food and Drug Administration found that only a quarter of people kept using a drug for at least three months, and only 10 per cent for at least 180 days. The clinical trials showed that those taking the recommended dose of Qsymia lost an average of 7.8 per cent of their weight after a year. Marty McNamara, who started taking Qsymia in November, said he had dropped from 424 to 332 pounds as his appetite has virtually disappeared. Two drugs used as part of the popular fen-phen combination were taken off the market in 1997 for damaging heart valves. For that reason, the FDA required that the drug be distributed through only a handful of mail-order pharmacies, a cumbersome process for doctors and patients. Medicare Part D does not cover weight-loss drugs, although a bill was just introduced to change that.
Lazarus said he sometimes prescribed the two generic drugs, which can cost as little as $40 a month.
It hopes that by the end of the first six weeks, people will have started to lose enough weight to stay on the drug.
Baker said she had not lost any weight yet, but said the drug made soda taste flat to her, allowing her to break her soft-drink habit. After rigorous testing for safety, this weight loss combination drug is awaiting FDA approval.  If approved, commercial launch of the drug is expected in the second half of 2014.
Among those receiving placebo, 27 percent lost 5 percent of their body weight, and one in 10 lost more than 10 percent of their body weight.
Serious side effects occurred in 6.2 percent of patients taking Saxenda and in 5 percent of those receiving the placebo, the researchers report.


Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City. Elias Siraj, director of the diabetes program at Temple University School of Medicine and Hospital in Philadelphia, said it's important to remember that obesity is a lifestyle condition. Those with a BMI of at least 27 may be approved by a doctor to use the drug if they have at least one weight-related condition such as hypertension, type 2 diabetes or high cholesterol. It’s the first new prescription drug for long-term weight loss to enter US in over a decade. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness. In April, the American Association of Clinical Endocrinologists included weight-loss drugs in its diabetes treatment guidelines. McNamara, a 6-foot-5 highway maintenance worker from Ridgecrest, Calif., said he now eats only fruit for lunch. In 2010, Abbott’s Meridia was withdrawn after a study suggested it might raise the risk of heart attacks and strokes. Recently, however, the agency agreed that qualified retail pharmacies could also dispense the drug. Only about one-third of Americans with private insurance have coverage for the drug, but often with co-payments of $50 a month or more.
The FDA’s ultimate verdict on Qnexa is due to be delivered in around three months time.The decision represented extremely bad news for Vivus, with 14 years having elapsed since a product was last approved for use within the US. An anticonvulsant, topiramate also stimulates weight loss, while phentermine suppresses the appetite, and both have already been individually approved by the FDA. Xavier Pi-Sunyer, professor of medicine at Columbia University Medical Center in New York City. As we noted in February, the pharmaceutical industry is desperate for new blockbuster drugs. By comparison, average weight loss with Qnexa is 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more. The patents on their biggest money-making drugs are expiring, which will cause drug prices and profits to plummet when generic versions become available, so the drug-makers are in a frenzy to find a new pill for a mass market.
Those who combined Contrave with intensive diet and exercise experienced the most reduction in body weight. In other words, if you weighed 200 pounds, you might lose about seven pounds over the course of a year.
Then there are the acknowledged side effects: depression, migraines, memory lapses, and attention disturbances. But for some reason, FDA thinks the benefits of taking an expensive pill to lose a tiny bit of weight outweigh the crippling headaches, mental problems, and depression. That is exactly what they did with another diet drug, Contrave, which has not yet been approved. Drug giant GlaxoSmithKline was just fined $2 billion because, among other violations, it marketed its antidepressant medications Paxil, Wellbutrin, and Avandia for unapproved uses—particularly for weight loss, even though there is no evidence it would be effective for this purpose. It is also worth noting that antidepressant drugs don't even appear to work for depression and can be highly addictive. Someone trying to lose weight is not likely to know about the addiction problem or be told about it.
Oddly, those who lost at least 5% of their body weight using the newly approved Belviq were specifically not patients with Type 2 diabetes—yet the FDA approved it for overweight people with at least one weight-related health condition, such as Type 2 diabetes.
Patients with diabetes may experience extra side effects, like low blood sugar, headache, back pain, cough and fatigue.
In 2010, FDA denied Belviq’s approval because of potential heart-valve risks and increased brain and breast tumor development. An FDA drug advisory panel has already recommended approval of one of them, Qnexa, a diet pill that has documented risks of causing birth defects and heart problems.
The only other currently FDA-approved weight loss drug is Alli, which has particularly nasty side effects like oily stools and flatulence—not to mention causing vitamin deficiencies and possible liver damage. One recent randomized, double-blind study points to the potential of unroasted coffee bean extract.
The extract contains chlorogenic acid, which helps tame blood sugar spikes and decrease weight. Best of all, 37% of the patients using coffee extract went from overweight (the pre-obesity range) back to their normal weight range. Other studies show that drinking twelve cups of coffee a day lowers the risk of diabetes by 67%.
But few of us can (or should) drink that much coffee each day, so research into a coffee extract is extremely promising indeed.
Unfortunately, green coffee bean extract and other nutraceuticals are always vulnerable to a rapacious drug industry that might want to turn such natural substances into drugs.
This is what precisely happened to pyradoxamine and could happen to P5P, the most bioavailable form of vitamin B6.
The only barrier to this theft under FDA rules is that pharmaceutical companies prefer to rely on synthetic versions of natural substances because they can be patented, and the companies can then charge whatever they wish. Attribution To ANH-USA.ORG The information in Pulse of Natural Health is for educational purposes only and should not be construed as medical advice.
Readers are advised to consult a qualified professional about any issue regarding their health and well-being.



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