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Release of Contrave data validates FDA's demand for second trial

March 4, 2015 1:47 AM UTC

Orexigen Therapeutics Inc. (NASDAQ:OREX) gained $1.85 (32%) to $7.64 after an interim analysis of the LIGHT cardiovascular (CV) outcomes study showed that the company's obesity drug Contrave naltrexone/ bupropion may have a cardiovascular benefit. The data release could compromise the ongoing trial, but FDA had already requested a second trial when it approved Contrave last fall.

Data from the LIGHT trial appeared in an SEC filing on Tuesday after the U.S. Patent and Trademark Office issued Cleveland Clinic and lead investigator on LIGHT, said that release of the interim data was "strictly forbidden" and was not approved by either the trial's data monitoring committee or its executive committee. ...