Orexigen reported that the screening of new patients for the Light Study, the cardiovascular outcomes trial evaluating Contrave is now complete. Approximately 9,000 patients will be randomized in the study within the next few weeks. An interim analysis of the Light Study will occur after approximately 87 major adverse cardiovascular events are accrued in the study. Although it is still too early to predict the rate of MACE, if the annual rate is close to the target of 1.5%, Orexigen anticipates resubmitting the Contrave New Drug Application and conducting the interim analysis in 2013, with potential approval as early as fourth quarter 2013.
- Pharmaceuticals & Drug Trials