Orexigen Therapeutics Inc endocrine news

Orexigen reduced headcount by 23 (40%) to save cash after a complete response letter from FDA earlier this month for obesity candidate Contrave. In the letter, the agency requested the company run a cardiovascular outcomes trial to show that the risk of major adverse cardiovascular events in patients receiving Contrave does not adversely affect the drug's benefit-risk profile. Orexigen plans to request a meeting with FDA to discuss the letter. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan) has exclusive rights to commercialize the fixed-dose combination of bupropion and naltrexone in North America (see BioCentury, Feb. 7). ...