Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced results from new intent to treat (ITT) analyses from the COR-I and COR-II Phase 3 trials of Contrave® (naltrexone SR/bupropion SR), the first of two late stage Orexigen candidates for the treatment of obesity. These data expand on top-line results announced in July and complement findings from a panel discussion on Saturday where the Company presented data on Contrave patients who completed 56 weeks of therapy. These ITT data were presented today in two late breaker oral presentations at the 27th Annual Scientific Meeting of The Obesity Society in Washington, D.C.
Results showed that, on an ITT basis,
- Approximately 25-33% lost 10% or more of their body weight and 12-16% lost at least 15%; and
- Obese patients on Contrave demonstrated significant improvements in important markers of cardiometabolic risk including waist circumference, HDL and triglycerides
"The data presented today and on Saturday provide a deeper view of Contrave, and what we believe is a balanced efficacy and safety profile," said Eduardo Dunayevich, M.D., Chief Medical Officer of Orexigen. "These findings should help clinicians assess the potential value of Contrave pharmacotherapy in managing obesity and support our belief that if approved, Contrave could meet the broad range of needs of this patient population by virtue of its efficacy, safety and benefits on key markers of cardiometabolic risk."