Orexigen jumps on Contrave interim analysis
Orexigen Therapeutics Inc. (NASDAQ:OREX) jumped on Monday after reporting that Contrave naltrexone/bupropion met FDA's pre-specified criteria for ruling out excess cardiovascular risk vs. placebo at an interim analysis in the Phase III Light Study trial, which is evaluating CV outcomes with the obesity product. Orexigen said it plans to resubmit an NDA for Contrave next month.
FDA requested the assessment of CV outcomes for Contrave in a complete response letter in 2011. In January, Orexigen said FDA proposed a procedure that would allow the summary report for the interim analysis of the Light Study to form the basis of the NDA resubmission instead of the complete clinical study report. Last month, Orexigen submitted an MAA to EMA for Contrave, which is partnered in North America with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). ...