FDA Declines to Approve Orexigen’s Contrave, Requests New Trial

Orexigen Therapeutics will have to conduct a new trial evaluating cardiovascular events related to its weight-loss drug Contrave to gain FDA approval, a prospect that could delay an NDA resubmission for several years. The company will need to perform a randomized, double-blind, placebo-controlled trial to show that the risk of major cardiovascular events does not negatively impact Contrave’s (naltrexone HCl/bupropion HCl) risk-benefit profile, according to a complete response letter issued Monday. Dawn Viveash, Orexigen’s senior vice president, said the company will formally request a meeting with the FDA and expects to meet with the agency this quarter.
Drug Industry Daily