FDA Reviewers Paint Mixed Picture of Orexigen’s Weight-Loss Drug Contrave

The FDA acknowledged the effectiveness of Orexigen’s obesity drug Contrave ahead of its consideration by an advisory committee Tuesday, but agency drug reviewers also expressed concern over potential safety issues associated with the treatment. The reviewers note in briefing documents that Contrave (naltrexone SR/bupropion SR) showed statistically significant weight loss results for patients in all four of its Phase III trials. But the studies also showed that cognitive-related adverse events, while infrequent overall, were reported by three times more patients taking Contrave than those taking a placebo, the FDA says.
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