Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that all three remaining Phase 3 trials evaluating Contrave(R) (bupropion SR/naltrexone SR), its investigational drug for the treatment of obesity, met their co-primary endpoints.
The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company’s plan to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first half of 2010.
Key top-line data from the COR Phase 3 program include the following:
— 48.0% and 56.3% of patients on Contrave32 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 across the entire 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 eating compared to placebo.-- Contrave was generally well tolerated by patients across the COR Phase 3 program. The COR program data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies."The successful completion of the COR Phase 3 program is a major milestone for Orexigen, 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 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."Source: Orexigen Therapeutics, USA