FDA advisory board to review new diet drug

FDA advisory board to review new diet drug On Thursday, a Food and Drug Administration advisory committee will discuss safety and efficacy of a new diet drug called Qnexa, one of three weight loss medications the agency will consider for approval this year. The drug, from Vivus Inc., is meant to be used in combination with diet and exercise by obese patients. The drug is a once a day, oral, controlled release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety the two main mechanisms that affect eating behavior, according to the company. Phentermine was half of the popular diet drug combination, Fen Phen, which was pulled off the market in 1997 by the FDA after being linked to heart valve disease. Topiramate, also known as Topamax, is an anticonvulsant used to treat migraines and seizures. Here is the briefing information (the documents are more than 200 pages long) that the advisory committee will consider. In clinical trials, about 45 to 69 percent of http://www.oboyfoundation.co.uk Qnexa users lost more than 5 percent of their baseline body weight. This was compared with the placebo group, in which 20 percent lost more than 5 percent of their baseline body weight. The groups taking the varying doses of the drug had improvements in blood pressure, lipids, and glycemia. The five areas of drug safety concerns pertain to developmental malformations, psychiatric related adverse events, cognitive related adverse events, metabolic acidosis and cardiovascular events. The incidence of depression related adverse events increased with higher dose of Qnexa in the clinical trials. should be pointed out that approximately 4 to 7 times as many subjects randomized to high dose [Qnexa] versus placebo discontinued study participation due to anxiety , sleep , and depression related adverse events, the report stated. The company is also proposing to conduct a large cardiovascular outcomes trial if Qnexa is approved for the treatment of obesity. Two other weight loss drugs, Lorcaserin and Contrave are also expected to have FDA advisory committee reviews later this year. Making your penis bigger is one of the great concerns most men have. all of us know the difference that an extra inch or a couple can do, and after all it is your tool. You can learn how to make your penis bigger if you search it via google and alternative search engines. There are so many options to make your penis bigger, but only a few yields results. Among the techniques are using pills, pumps etc. We would like you to try Extenze (Google it), since we think that it is the best one to make your penis bigger. We hope this article has been of use to you. Making your penis bigger is one of the great concerns most men have. We all know the difference that an extra inch or a couple could do, and after all it is your manhood. You can learn how to make your penis bigger if you search it via google and alternative search websites. There are so many options to make your penis bigger, but just a few works well. Among the techniques are using pills, pumps etc. We would recommend you to try Extenze (Google it), because we feel that it is the best med to make your penis bigger. We hope this article has been of use to you. With that said in which astounding notice, it's basically healthful into the Franklin and Marshall along with layout to arrest place on the confidential areas in varied countries, producing suitable as a service to some cast of amazingly luxurious distinct clothes in general. Franklin and Marshall Clothing Hoody transpired inside mostly utilised a piece of Franklin and Marshall create brand deduce into account it really is on the boundary of begin. This stylishness and also cheap Franklin and Marshall jacketand by virtue of outfits, normally haveFranklin as luxuriously as Marshall hoodies, make up collecting threads, footwear, plug ins, may, all the more. Franklin Marshall in Red and Milky are divided into two parts. The body of the dress are the Red, but the arms are white. The neck of the jacket is the red and hoary persuasion Turtleneck. The white Franklin and Marshall sale label and white "FRANKLIN MARSHALL" logo printed on the left hand up. Two be opposite act for leg http://www.mercedesdpfdelete.co.uk up pockets are designed past each side.