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Orexigen(R) Therapeutics Announces Second Quarter 2009 Financial Results
Date:8/6/2009

gen, and the results demonstrate the potential for Contrave to help patients in their battle against obesity," said Mike Narachi, President and CEO of Orexigen. "These results highlight the benefits of Contrave, a novel combination therapy that was specifically designed to address the behavior and reward pathways in the brain that impact one's ability to initiate and sustain weight loss."

Recent Highlights

Contrave

Orexigen announced that the three remaining Phase 3 trials in the Contrave Obesity Research, or COR, program met their co-primary endpoints. Key top-line data from the COR Phase 3 program include the following:

  • 48.0% and 56.3% of patients on Contrave32(1) in COR-I (NB-301) and COR-II (NB-303) lost at least 5% of their body weight after 56 weeks, approximately three times the placebo categorical response rates of 16.4% and 17.1%, respectively (ITT, p<0.001).
  • Contrave patients in COR-I and COR-II on Contrave32 had mean weight loss of 6.1% and 6.4% after 56 weeks, compared to 1.3% and 1.2% on placebo, respectively (ITT, p<0.001).
  • In the COR-Diabetes (NB-304) trial, 44.5% of patients on Contrave32 lost greater than or equal to 5% of their body weight after 56 weeks, more than double the 18.9% of patients on placebo (p<0.001). Contrave patients also showed a 0.6% reduction in HbA1c from baseline, compared to a 0.1% reduction in placebo. This difference of 0.5% is clinically and statistically significant (ITT, p<0.001).
  • Key secondary endpoints met in the COR Phase 3 program included significant improvements in cardiovascular and metabolic risk factors such as waist circumference, visceral fat, HDL cholesterol and triglycerides.
  • Additional analyses indicate that Contrave patients experienced reductions in the frequency and strength of food cravings and an increased ability to control their eati
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SOURCE Orexigen Therapeutics, Inc.
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