New weight loss medication Qnexa receives approval from FDA advisors
A committee of medical experts on Wednesday voted to endorse ‘Qnexa’, a weight loss medication that has been produced by Vivus, Inc., and which was first rejected by the US regulator in April 2010 after they requested more information about the drug. It now seems likely that the Food and Drug Administration (FDA) will finally approve a new prescription weight loss medication for the first time in 13 years. The new drug will be targeted at those who are overweight or obese and have problems such as central andiposity, hypertension, type 2 diabetes, and dyslipidemia. Qnexa is one of three weight loss prescription medications attempting to gain the first U.S. approval since Swiss drug company ‘Roche’ succeeded in 1999 with Xenical. A lower dose over the counter version of Xenical has since been introduced into the market by GSK, going by the name of ‘Alli’. This gained FDA approval in 2007. If Qnexa is given the go-ahead by the FDA, some analysts are predicting a whopping $448 million to be generated in sales by 2015. President of Vivus, Peter Tam, is clearly thrilled by the latest developments, commenting: “We are pleased with the panel’s approval recommendation in support of the safety and efficacy of Qnexa.” He went on to add, “Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic.” Although the FDA isn’t obliged to act upon the panel’s 20-2 majority vote in favour of Qnexa, it does bode well for Vivus that the panel decided it’s benefits far outweighed any potential risks. Over 4,000 subjects were part of a clinical trial of the drug and there was an average loss of roughly 10% body weight in the first 12 months of use. Some also experienced an improvement in blood pressure. However, it was discovered that Qnexa can also cause a slight increase in heart rate, boosting the chance of a stroke or heart attack. On top of this, experts found that some women who became pregnant whilst on the drug, gave birth to a baby with a defect. The most common birth defect was a cleft lip. Vivus, Inc. counteracted this concern by suggesting a strictly controlled system in regards to who can be prescribed it, and any women who are taking Qnexa will have to undergo monthly pregnancy testing. Moreover, It has been proposed that distribution of the drug will be restricted to registered pharmacies. If you are overweight or obese and are looking to lose weight, Medical Specialists Pharmacy we can help you. Until the possible arrival of Qnexa into the market, Xenical is currently the only clinically proven and prescription only slimming medication available. It works in the digestive system, blocking roughly one-third of the fat in the food you eat from being digested and absorbed by your body. Alli is a slightly weaker version of Xenical and can be obtained from our chemist shop without a prescription, the only FDA approved medication of it’s kind.