The company reported on Monday that it has reached at an agreement with U.S. Food and Drug administration (FDA) over the details of design and analysis of the experimental drug.
"We are pleased to receive agreement on the SPA (Special Protocol Assessment) from the FDA after just one cycle of review," said Michael Narachi, President and CEO of Orexigen. "A few months ago, we received detailed written correspondence from the FDA's Director of the Office of New Drugs that identified a clear and feasible path forward for this important potential obesity therapy. We believe the rapid progress we have since made with the FDA's Division of Metabolic and Endocrinologic Products on the detailed protocol and plans for analysis is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA."
The company will work on 10,000 patients in a placebo-controlled trial to prove that there are very less chances of unacceptable increased adverse cardiovascular events.