Monthly Archives: February 2012

Enlarge this image carly weeks Globe and Mail Blog Posted on Friday, February 17, 2012 1:04PM EST Is a new weight-loss drug about to hit the market? The U.S. Food and Drug Administration has ignited rampant discussion about the possibility, after announcing its plan to review the treatment known as Qnexa. The reason for all the excitement? Clinical trials have shown that people who take Qnexa lose significant amounts of weight; a trial published in 2009 showed patients on the drug lost an average of nearly 17 kilograms (37 pounds). More related to this story The FDA rejected approval of the drug in 2010, however, because of nagging concerns it may increase the risk of birth defects and heart problems. On Friday, the FDA reiterated its stance that Qnexa may cause serious side effects. But regulators have decided to review Qnexa’s status after receiving additional information about the drug’s effectiveness and safety. If it gets the green light, the drug could lead to major changes in how obesity is treated. Although other weight-loss drugs are on the market, many fail to produce major changes or come with risk of serious side effects. One drug, sibutramine, sold under the brand name … Continue reading →

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SALT LAKE CITY &#8212 Researchers have discovered that a drug used to treat cancer may have benefits for sufferers of Alzheimer's disease. According to neuroscientists at Case Western Reserve University, use of the drug Bexarotene in mice led to quick reversals of pathological, cognitive and memory deficits caused by the disease. Bexarotene has been Food and Drug Administration-approved for the treatment of cancer for more than a decade. Now, researchers say there is good reason to look into approving it for the treatment of Alzheimer's disease. When treated with the drug, soluble amyloid levels in mice fell by 25 percent within six hours. The effects lasted for up to three days. Soluble amyloid buildup in the brain is what causes the memory impairments that are symptoms of Alzheimer's, scientists believe. Also within three days of being administered with the drug, the mice showed marked behavioral improvement. Researchers found that their nesting instinct, which seemed to have disappeared in Alzheimer's-diseased mice, reappeared in mice treated with the drug. This is an unprecedented finding. –Paige Cramer "Many often think of Alzheimer's as a problem of remembering and learning," said Dr. Daniel Wesson, a co- author of the study. "But the prevalent reality … Continue reading →

By Brian Orelli | More Articles February 17, 2012 | The headlines make the briefing documents for the Food and Drug Administration advisory panel reviewing VIVUS' (Nasdaq: VVUS  ) Qnexa sound horrible: "FDA raises safety concerns for Vivus diet pill" "Vivus obesity drug has safety risks -- US FDA staff" But the 3% increase the market awarded VIVUS today more accurately reflects the information in the briefing documents for the panel next week: No new issues is good news. The FDA is still concerned with the oral clefs seen in babies of women taking Johnson & Johnson's epilepsy medication Topamax, one of the active ingredients in Qnexa. VIVUS doesn't need the advisory panel to say that there isn't a risk; I doubt it will, considering the data. The panel of experts just needs to conclude that the risk is low enough that educating doctors not to prescribe it to pregnant patients will solve the problem. The FDA has already lightened up on the issue, requesting a change from excluding women who are capable of getting pregnant to just those that are currently or are planning to become pregnant. The bigger issue VIVUS might run into is the potential need for a … Continue reading →