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Orexigen Therapeutics, Inc. Reports Enrollment Trend In Contrave Study-DJ


Wednesday, 11 Jul 2012 08:18am EDT 

Dow Jones reported that Orexigen Therapeutics, Inc. expects to complete enrollment in an interim study of cardiovascular risks associated with its weight loss treatment Contrave in the first quarter next year, potentially reducing its initial estimates by half. Orexigen had suspended U.S. development of Contrave last year after regulators asked it to conduct additional clinical tests that the company said were unnecessary. But the company renewed its development when the Food and Drug Administration in September said it could approve Contrave if an interim analysis meets specified criteria on cardiovascular risk. The company said since early June that more than 1,500 patients with the targeted risk profile had been enrolled at about 100 clinical trial sites. Orexigen said it plans to have an additional 200 test sites on line by the end of next month. The company said as a result of the revised enrollment projections, it could potentially be ready to conduct its interim analysis in the second half of next year. Orexigen plans submit its application for FDA approval if interim analysis allows the company to exclude a doubling of risk of cardiovascular events in patients receiving Contrave compared with a placebo. 

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