FDA panel recommends approval for naltrexone and bupropion weight-loss drug.
ABC World News (12/7, story 6, 0:20, Sawyer) reported, "Big news on a diet drug tonight. After two drugs were rejected recently, a panel of advisers today recommended the FDA approve a pill called Contrave (naltrexone and bupropion), which is both an anti-depressant and acts to block addictive behavior."
The Los Angeles Times (12/8, Healy) reports, "An advisory panel to the Food and Drug Administration set aside lingering concerns about the safety and marginal effectiveness of the latest weight-loss drug to come before it, voting 13 to 7 on Tuesday to recommend the approval of Contrave, a combination of two medications available since the mid-1980s." The "vote made Contrave the first of three weight-loss drugs reviewed by the FDA panel in 2010 to win favor." In four different "clinical trials presented to the panel at Tuesday's meeting outside Washington, Contrave was found to have helped obese subjects lose more weight than a dummy pill."
Bloomberg News (12/8, Larkin) reports Orexigen Therapeutics Inc. and partner Takeda Pharmaceutical Co. "avoided safety concerns that delayed competing products from Arena Pharmaceuticals Inc. and Vivus Inc. in October." The FDA "hasn't approved a prescription diet pill since 1999 for the almost two-thirds of US adults who struggle with their weight."
The AP (12/8) reports, "Experts had voiced safety concerns on the drug, but determined the benefits outweigh the risks." FDA scientists "are concerned over Contrave's effects on the heart, an issue that has weighed heavy on potential weight loss drugs." The complaints "focused on the company's lack of elderly patients with a history of heart disease in clinical trials. That lack of data made it difficult to determine the drug's safety in patients at risk for heart attack and stroke."
The San Diego Union-Tribune (12/8, Calbreath) adds, "Contrave is no silver bullet against obesity. Clinical studies show that most users can only expect a weight loss of 5 percent to 10 percent, with even higher losses achieved with diet and exercise." Many "experts on obesity said that even a 5 to 10 percent weight loss is a significant first step in combating obesity." The Wall Street Journal (12/8, Dooren, subscription required), the New York Times (12/8) "Prescriptions" blog, and the Washington Post (12/8, Stein) "The Checkup" blog also report the story.
Saturday, December 11, 2010
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