FDA, Orexigen agree on SPA for Contrave trial

Orexigen Therapeutics Inc. (NASDAQ:OREX) said it reached agreement with FDA on an SPA for the cardiovascular outcomes trial of obesity product Contrave that the agency requested in a complete response letter last year. The trial, expected to begin in late 2Q12, will enroll about 10,000 patients. An interim analysis and NDA resubmission are planned after about 87 major cardiovascular events (MACE), which Orexigen expects to occur less than two years after the trial start. Orexigen gained $0.45 (16%) to $3.21 on Monday. ...