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A new weight-loss pill that many doctors consider the most effective of a new generation of anti-obesity drugs got the approval of the Food and Drug Administration on Tuesday. The pill, called Qsymia, was approved for patients who are overweight or obese and also have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
The drug offers hope for those who have failed to lose weight in other ways, but its path to approval also underscores how difficult it has been for drugmakers to find obesity treatments that are safe and effective. The drug's maker, Vivus Inc., said it plans to bring the drug to market in the fourth quarter of this year. In testing, the drug made led patients to lose more weight than two other weight-loss pills recently review by the FDA. Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough.
Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Researchers say the innovation of Qsymia lies in targeting more than one of the brain signals that drive people to overeat. Qsymia is the second weight-loss drug approved by the FDA in less than a month, following Arena Pharmaceutical's pill Belviq in late June.
The FDA's approvals of Qsymia and Belviq suggest a new willingness to make weight-loss medications available, even in the face of lingering safety issues.
The FDA initially rejected Vivus' drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency also said patients with recent or unstable heart disease or stroke aren't good candidates for the drug because its effect on heart rates in those patients is not known.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus plans a slow rollout. Contrave is a combination of two FDA-approved drugs, the antidepressant bupropion and the anti-addiction drug naltrexone, in an extended-release formula. Contrave is approved for use in adults who are either overweight (BMI of 27 or greater) with at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol, or have a BMI of 30 or greater (obesity). Some people should not use the drug , including anyone with a seizure disorder, eating disorder, uncontrolled hypertension, those already on opioids, or women who are pregnant or trying to get pregnant, among other contraindications listed in the prescribing information. The amount of expected weight loss is an average of 5% to 10% of starting weight, according to results achieved by patients in multiple clinical trials. The drug also comes with a boxed warning about the increased risk of suicidal thoughts and behaviors, and neuropsychiatric reactions, that are linked with the antidepressant drug bupropion.
The cost has not yet been announced by the company, but many experts expect Contrave to have a price similar to the other two prescription weight loss drugs (Qsymia and Belviq) already on the market.


The approval of Contrave will provide patients and doctors with another pharmaceutical option for treating overweight and obesity. Source: FDA News Release “FDA approves weight-management drug Contrave” September 10, 2014.
More thanA a third of AmericansA are obese, and while pharmaceutical companies have been racing to find a treatment with blockbuster potential, Katz suggests that prescribing an anti-obesity drug should not become the standard treatment. Insurers have historically been reluctant to cover drugs that target obesity, making widespread adoption unlikely unless their position changes. Contrave is a combination of two previously approved drugs that have been observed to reduce appetite: bupropion, often prescribed for depression and smoking cessation under the brand names Welbutrin and Zyban, and naltrexone (Vivitrol), which is primarily used to fight alcohol and opioid dependence. Orexigen TherapeuticsA first sought FDA approval for Contrave in 2011 but was asked to conduct additional testing of cardiovascular risks. In June, the FDA delayed approval again until the label was updated with a warning that side effects may include increased suicidal thoughts, a standard warning on many antidepressants. Now Orexigen has won approval from the FDA, although there's no information yet on how much the drug will cost or when exactly it will be available.
In one trial, among people without diabetes, fewer than half (42%) of participants taking Contrave lost at least 5% of their body weight, compared to 17% of patients taking a placebo pill. Along with the warning about increased risk for suicidal thoughts, labeling will also note that "serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation," the FDA reports. The most common adverse reactions people in trials had when taking Contrave wereA nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. ReutersThe infamous "fen-phen" was withdrawn in 1997 after its risks were deemed unacceptable.Back in 1997, the popular combo appetite suppressant known as fen-phen was withdrawn after fenfluramine, one of its main components, was linked to heart valve defects and otherA cardiac abnormalities. Belviq, Qsymia, and Contrave are very different, pharmacologically, but not hugely different in terms of results. Contrave is not a solution to the obesity epidemic, and it's certainly not the best plan of action for most people struggling with excess weight.
Still, when people are trying to lose weight, "there needs to be a long-term plan for lifestyle change," Katz advised. The drug is actually a combination of two older drugs long known to help with weight loss: phentermine and topirimate. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satisfied after eating.
The cocktail of phentermine and fenfluramine was a popular weight-loss combination prescribed by doctors, though it was never approved by the FDA. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased risks for heart attack and stroke. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors. However, FDA regulators ordered the company to change the name to avoid potential confusion with similar-sounding drugs.


It is intended as a treatment option for chronic weight management in addition to a reduced calorie diet and physical activity.
To achieve successful weight loss, patients will need to follow a reduced calorie diet and participate in regular physical activity. Always seek the advice of your physician or other qualified health professional before starting any new treatment, making any changes to existing treatment, or altering in any way your current exercise or diet regimen. The primary ingredients were herbal laxatives.The Food and Drug Administration has approved Contrave "as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity," the agency announced on Wednesday. Finding a way to improve diet and increase physical activity is still considered the best approach for the vast majority of people looking to lose weight.
As with other anti-obesity pharmaceuticals, the weight lost during trials was modest, not transformative. That testing, which is ongoing, is costing the company $100 million, according to FierceBiotech, and the FDA is now requiring post-approval follow-up research on cardiovascular risks, safety for children, and more. First, the drug is meant to be used alongside, not in place of, a reduced-calorie diet and exercise. Results were slightly worse among participants with diabetes: 36% of those on Contrave lost at least 5% of body weight compared to 18% of those on the placebo.
Other possible side effects include seizures as well as elevated blood pressure and heart rate. More recently, the FDA withdrew approval for the diet drug sibutramine due to an increase in "nonfatal cardiovascular events."A That may have given the agency pause when other diet pills came up for approval. And an over-the-counter drug, orlistat (known under the brand name Alli in the United States), disrupts fat absorption, aiding in weight loss a€” and often causing numerous gastrointestinal side effects.
After investing a huge amount of money to develop the drug, Orixgen has 900 sales reps lined up to pitch it to doctors a€” but it may not be as popular as the company hopes. The company said patients on the strongest formulation tested lost nearly 11 percent of their weight. But a long line of prescription diet pills have been associated with dangerous side effects, particularly heart problems.
It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014. After sibutramine (sold as Meridia) was pulled from shelves in 2010 due to "increased risk of heart attack and stroke," Alli was briefly the only approved weight loss drug available in the U.S.



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