The obesity pill Contrave helped patients lose weight in clinical trials but failed to meet all the criteria set forth by the U.S. Food and Drug Administration, agency scientists said in a review posted online Friday.
The four clinical trials conducted by drug maker Orexigen Therapeutics Inc. found that patients taking Contrave averaged 4.2 percent more weight loss than those taking a placebo. But that fell short of an FDA guideline of at least a 5 percent difference, the Associated Press reported.
Side effects such as high blood pressure, dizziness and insomnia were experienced by patients taking Contrave, which is a combination of the antidepressant bupropion and the anti-addiction drug naltrexone.
The FDA review was posted in advance of next Tuesday's meeting of an outside panel of experts who will discuss Contrave's efficacy and safety and vote on whether to recommend FDA approval of the drug, the AP reported. The FDA typically follows the advice of its expert panels.
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