Orexigen's actions in gaining approval for obesity drug Contrave showed a 'real breakdown' in process, says former FDA senior official

17 March 2016

Alleged failures to follow regulations by US pharma company Orexigen Therapeutics (Nasdaq: OREX) in its trial of obesity drug Contrave must not “become a trend,” former US Food and Drug Administration deputy commissioner Joshua Sharfstein told The Pharma Letter.

He has expressed his disappointment with the actions of Orexigen in publishing early and “misleading” trial data public about Contrave (naltrexone HCl/bupropion HCl) and whether it has a cardiovascular benefit.

The company calls Contrave the USA’s leading branded prescription treatment option for certain overweight and obese adults for chronic weight management.

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