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18,541,484 articles and booksPeriodicalsLiteratureKeywordTitleAuthorTopicMember loginUser name Password Remember meJoin us Forgot password? TopLine();dw('
');Translate()Submit articles freeThe Free Library > Business and Industry > Business > AP Features > December 3, 2010The Free Library > Business and Industry > Food and beverage industries > AP Features > December 3, 2010The Free Library > Business and Industry > Travel industry > AP Features > December 3, 2010The Free Library > Communications > News, opinion and commentary > AP Features > December 3, 2010The Free Library > Entertainment/The Arts > Arts and entertainment industries > AP Features > December 3, 2010The Free Library > General Interest/Informational > General interest > AP Features > December 3, 2010The Free Library > Law/Government/Politics > International relations > AP Features > December 3, 2010The Free Library > Law/Government/Politics > Politics > AP Features > December 3, 2010The Free Library > Recreation and Leisure > Sports and fitness > AP Features > December 3, 2010 The Free Library > Date > 2010 > December > 3 > AP FeaturesFDA scrutinizes weight loss pill from Orexigen
diggit();LinkToThis()Scientists for the Food and Drug Administration said Friday a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn't meet all the criteria set forth by the agency.
The FDA's review, posted online Friday, also raised questions about the pill's effects on the heart, a perennial issue for weight loss drugs Weight Loss Drugs Definition
Weight loss drugs are medications that may help an obese person lose weight in combination with a low-calorie diet and physical activity.
Purpose
More than 60% of American adults are overweight or obese. that have been plagued by safety issues.
Orexigen's pill Contrave is the third weight loss pill to be reviewed by the FDA this year. FDA officials have acknowledged the need for new weight loss drugs amid an epidemic of U.S. obesity, though the agency rejected the two other medications due to safety concerns.
Shares of Orexigen Therapeutics Inc., based in La Jolla La Jolla (l? hoi`y?), on the Pacific Ocean, S Calif., an uninc. district within the confines of San Diego; founded 1869. The beautiful ocean beaches, in particular La Jolla shores and Black's Beach, and sea-washed caves attract visitors and , Calif., fell 73 cents, or 13 percent, to $4.74 in morning trading.
The FDA said Friday four studies conducted by Orexigen showed patients taking its drug lost, on average, 4.2 percent more weight than patients taking a placebo. However, the results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups.
The drug did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight. FDA guidelines published in 2007 state that a drug can be considered effective if it meets this requirement.
The FDA will ask a panel of experts to vote on the drug's efficacy and safety on Tuesday. The vote is non-binding, though the FDA often follows the guidance of its panelists.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.
But the search for a drug that helps patients safely shed pounds has been largely unsuccessful. Earlier this year Abbott Laboratories' Meridia weight loss pill was pulled from the market after regulators said it increased the risk of heart attack and stroke.
In reviewing Contrave, FDA scientists complained that the company enrolled few elderly patients or patients with a history of heart disease in its trials, making it difficult to determine the drug's safety in patients at risk for heart attack and stroke.
Contrave is a combination pill, mixing the antidepressant bupropion bupropion /bu·pro·pi·on/ (bu-pro´pe-on) a monocyclic compound structurally similar to amphetamine, used as the hydrochloride salt as an antidepressant and as an aid in smoking cessation. with the anti-addiction drug naltrexone naltrexone /nal·trex·one/ (nal-trek´son) an opioid antagonist used as the hydrochloride salt in treatment of opioid or alcohol abuse.
nal·trex·one
n.
An endorphin and narcotic antagonist. . FDA reported higher rates of side effects Side effects
Effects of a proposed project on other parts of the firm. already linked to the drugs, including high blood pressure, dizziness and insomnia insomnia, abnormal wakefulness or inability to sleep. The condition may result from illness or physical discomfort, or it may be caused by stimulants such as coffee or drugs. However, frequently some psychological factor, such as worry or tension, is the cause. .
The quest for Verb 1. quest for - go in search of or hunt for; "pursue a hobby"
quest after, go after, pursue
look for, search, seek - try to locate or discover, or try to establish the existence of; "The police are searching for clues"; "They are searching for the a blockbuster weight loss drug has been plagued for decades by safety issues. Doctors and patients had hoped a new wave of treatments submitted to the FDA would prove safer than older therapies. But in October the FDA rejected two drugs in one week: Qnexa from Vivus Inc. and lorcaserin from Arena Pharmaceuticals Inc.
Qnexa had shown significant weight loss in trials but was linked to potential heart problems and birth defects. In lorcaserin's case, the FDA raised concerns about cancerous tumors seen in rats who took the drug.
Copyright 2010 AP Features
No portion of this article can be reproduced without the express written permission from the copyright holder. Copyright (c) Mochila, Inc. SocialNetworks() Reader Opinion Title:
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18,541,484 articles and booksPeriodicalsLiteratureKeywordTitleAuthorTopicMember loginUser name Password Remember meJoin us Forgot password? TopLine();dw('
');Translate()Submit articles freeThe Free Library > Business and Industry > Business > AP Features > December 3, 2010The Free Library > Business and Industry > Food and beverage industries > AP Features > December 3, 2010The Free Library > Business and Industry > Travel industry > AP Features > December 3, 2010The Free Library > Communications > News, opinion and commentary > AP Features > December 3, 2010The Free Library > Entertainment/The Arts > Arts and entertainment industries > AP Features > December 3, 2010The Free Library > General Interest/Informational > General interest > AP Features > December 3, 2010The Free Library > Law/Government/Politics > International relations > AP Features > December 3, 2010The Free Library > Law/Government/Politics > Politics > AP Features > December 3, 2010The Free Library > Recreation and Leisure > Sports and fitness > AP Features > December 3, 2010 The Free Library > Date > 2010 > December > 3 > AP FeaturesFDA scrutinizes weight loss pill from Orexigen
diggit();LinkToThis()Scientists for the Food and Drug Administration said Friday a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn't meet all the criteria set forth by the agency.
The FDA's review, posted online Friday, also raised questions about the pill's effects on the heart, a perennial issue for weight loss drugs Weight Loss Drugs Definition
Weight loss drugs are medications that may help an obese person lose weight in combination with a low-calorie diet and physical activity.
Purpose
More than 60% of American adults are overweight or obese. that have been plagued by safety issues.
Orexigen's pill Contrave is the third weight loss pill to be reviewed by the FDA this year. FDA officials have acknowledged the need for new weight loss drugs amid an epidemic of U.S. obesity, though the agency rejected the two other medications due to safety concerns.
Shares of Orexigen Therapeutics Inc., based in La Jolla La Jolla (l? hoi`y?), on the Pacific Ocean, S Calif., an uninc. district within the confines of San Diego; founded 1869. The beautiful ocean beaches, in particular La Jolla shores and Black's Beach, and sea-washed caves attract visitors and , Calif., fell 73 cents, or 13 percent, to $4.74 in morning trading.
The FDA said Friday four studies conducted by Orexigen showed patients taking its drug lost, on average, 4.2 percent more weight than patients taking a placebo. However, the results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups.
The drug did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight. FDA guidelines published in 2007 state that a drug can be considered effective if it meets this requirement.
The FDA will ask a panel of experts to vote on the drug's efficacy and safety on Tuesday. The vote is non-binding, though the FDA often follows the guidance of its panelists.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.
But the search for a drug that helps patients safely shed pounds has been largely unsuccessful. Earlier this year Abbott Laboratories' Meridia weight loss pill was pulled from the market after regulators said it increased the risk of heart attack and stroke.
In reviewing Contrave, FDA scientists complained that the company enrolled few elderly patients or patients with a history of heart disease in its trials, making it difficult to determine the drug's safety in patients at risk for heart attack and stroke.
Contrave is a combination pill, mixing the antidepressant bupropion bupropion /bu·pro·pi·on/ (bu-pro´pe-on) a monocyclic compound structurally similar to amphetamine, used as the hydrochloride salt as an antidepressant and as an aid in smoking cessation. with the anti-addiction drug naltrexone naltrexone /nal·trex·one/ (nal-trek´son) an opioid antagonist used as the hydrochloride salt in treatment of opioid or alcohol abuse.
nal·trex·one
n.
An endorphin and narcotic antagonist. . FDA reported higher rates of side effects Side effects
Effects of a proposed project on other parts of the firm. already linked to the drugs, including high blood pressure, dizziness and insomnia insomnia, abnormal wakefulness or inability to sleep. The condition may result from illness or physical discomfort, or it may be caused by stimulants such as coffee or drugs. However, frequently some psychological factor, such as worry or tension, is the cause. .
The quest for Verb 1. quest for - go in search of or hunt for; "pursue a hobby"
quest after, go after, pursue
look for, search, seek - try to locate or discover, or try to establish the existence of; "The police are searching for clues"; "They are searching for the a blockbuster weight loss drug has been plagued for decades by safety issues. Doctors and patients had hoped a new wave of treatments submitted to the FDA would prove safer than older therapies. But in October the FDA rejected two drugs in one week: Qnexa from Vivus Inc. and lorcaserin from Arena Pharmaceuticals Inc.
Qnexa had shown significant weight loss in trials but was linked to potential heart problems and birth defects. In lorcaserin's case, the FDA raised concerns about cancerous tumors seen in rats who took the drug.
Copyright 2010 AP FeaturesNo portion of this article can be reproduced without the express written permission from the copyright holder. Copyright (c) Mochila, Inc. SocialNetworks() Reader Opinion Title:
Comment:
Article Details
Printer friendly Cite/link Email FeedbackAuthor:StaffPublication:AP FeaturesDate:Dec 3, 2010Words:496Previous Article:US judge orders removal of GMO seed plantsNext Article:Caricom to launch ID cards for regional travelPublications by NamePublications by DateAuthorsLiteratureA-D E-O P-T U-Z before 1995 1995-1999
2000-2004 2005-20092010-A B C D E F G H I J K L M
N O P Q R S T U V W X Y Z A B C D E F G H I J K L M
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