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21.09.2014
Contrave’s maker had hoped for approval three years ago, but the FDA first demanded a safety study. It’s approved for use in obese adults and clinically overweight adults who suffer from high blood pressure, type 2 diabetes, or high cholesterol. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese. The drug should not be used in patients who have eating disorders (bulimia or anorexia nervosa).
The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. The FDA approved a new weight loss drug that many doctors consider the most effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds.
Contrave should also not be taken by patients who are using opioids or treatments for opioid dependence, or who are experiencing acute opiate withdrawal. Image: Associated Press The Food and Drug Administration approved a new weight loss drug from Vivus Inc.
Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave.
The agency cleared the pill Qsymia for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol. Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough, and its development underscores the slow pace of research for obesity treatments.


The drug is actually a combination of two older drugs that have long been known to help with weight loss: phentermine and topirimate. Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, which makes people feel more satiated after eating. Researchers say the innovation of Qsymia lies in targeting multiple 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.
But a long line of prescription diet pills have been associated with dangerous side effects, particularly heart problems. 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 heart attack and stroke. The FDA’s successive approval of Qsymia and Belviq suggests 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 laid out a risk-management plan specifically designed to minimize the chance of the women becoming pregnant while using the drug.


It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.
The agency also says 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 Inc.
The pill will launch in the last quarter of the year with a relatively small sales force of 150 representatives. 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. 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.



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