ARTICLE | Regulation
Pandora's CVOT
Contrave highlights data protection conundrum facing CV outcomes studies
September 22, 2014 7:00 AM UTC
Related article: Weighing in on obesity
After more than three years and multiple setbacks related to establishing Contrave naltrexone/bupropion's cardiovascular safety, Orexigen Therapeutics Inc.'s obesity drug finally won FDA approval this month. But concerns over confidentiality of an interim analysis scuttled Orexigen's attempts to use a single CV outcomes trial to fulfill pre- and postmarket safety requirements...