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Orexigen® Therapeutics Announces Publication of COR-I Phase 3 Study of Contrave in Lancet
Date:7/29/2010

ntial to be an important new approach to the treatment of obesity."

Additional findings from patients on Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR):

  • 34% of patients completing the study lost at least 10% of their body weight as compared to 11% on placebo (p<0.0001).
  • Patients taking Contrave showed significant improvements in important secondary endpoints: waist circumference (-6.2 cm on Contrave32 vs. -2.5 cm on placebo), insulin resistance (-20.2% vs. -5.9%), HDL cholesterol (+8.0% vs. +0.8%), triglycerides (-12.7% vs. -3.1%) and hsCRP (-29.0% vs. -16.7%) compared to patients taking placebo on an ITT basis.

The most frequently observed treatment-emergent adverse events in COR-I included nausea, headache, constipation and upper respiratory tract infection. Adverse events in the Contrave groups were generally mild to moderate in intensity, transient, and did not result in discontinuation for most patients. Mean systolic blood pressure decreased from baseline to endpoint by 1.6 mmHg for patients taking Contrave32 and 2.8 mmHg for patients on placebo. As expected, greater weight loss was associated with greater reductions in blood pressure.

"As a clinician, I was comforted to see that the safety findings from the largest of the Phase 3 studies of Contrave were consistent with the known effects of its constituent components," said Ken Fujioka, M.D., Director of Nutrition and Metabolic Research at Scripps Clinic and investigator in this study. "When studying a combination therapy, a primary goal is making sure that the combination does not result in a different safety profile from what is already known about the constituent components. Contrave achieved that goal: the adverse event profile was consistent with the 20-year h
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SOURCE Orexigen Therapeutics, Inc.
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