Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced the online publication of results from its COR-BMOD trial of Contrave® (naltrexone SR/bupropion SR) in the journal Obesity. The COR-BMOD trial evaluated intensive behavior modification (BMOD) plus Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) compared to BMOD plus placebo, in 793 overweight or obese patients. The addition of Contrave to BMOD delivered significant incremental weight loss and improvements in measures of cardiometabolic risk. Results showed that patients taking Contrave lost 9.3% of their body weight compared to 5.1% for patients on placebo (p< 0.001), on an intent-to-treat basis. For those who completed 56 weeks of treatment, patients taking Contrave plus BMOD lost 11.5% of their body weight compared to 7.3% for those taking placebo (p<0.001).
Behavior modification, including diet and exercise, has long been considered the standard of care in managing obesity. The benefit of adding specific pharmacotherapies to a rigorous BMOD program has not been extensively evaluated. COR-BMOD was designed to test this hypothesis by evaluating Contrave in a setting conducive to maximum weight loss in which patients used the medication as part of a broader weight-loss effort. Participants in both groups received diet and exercise counseling during 28 small group sessions with one or two professionals, each lasting 90 minutes, over the course of the year-long trial.
"There is no magic bullet for the treatment of obesity. For some patients, effective and sustainable treatment is going to require a multi-modal approach which may include a combination of behavior modification and pharmacotherapy," said Thomas Wadden, Ph.D., lead investigator and Professor of Psychology in Psychiatry at the University of Pennsylvania School of Medicine and Director of the Center for Weight and Eating Disorders. "This study clearly demonstrates that when Contrave is added to a state of the art diet and exercise regimen, patients can achieve significant incremental weight loss."
Results showed that the addition of Contrave to intensive behavior modification was also associated with statistically significant greater improvements in markers of cardiometabolic risk, including waist circumference, triglycerides, high density lipoprotein (HDL) cholesterol and fasting insulin. The most common adverse events included nausea, headache, constipation and dizziness. Observed adverse events were, in general, consistent with the other studies within the COR program and with the safety profile of the constituent components.
"Medication alone may not be the answer for the majority of obese patients, so it's important that we understand the benefits of a multi-modal weight loss program," said Michael Narachi, CEO of Orexigen. "The results from this study reinforce our belief that a weight management strategy, addressing both the biological and behavioral drivers of obesity, can be successful."
Study Design
COR-BMOD was a 56-week placebo-controlled, double-blind, randomized trial that enrolled overweight and obese adults. A total of 793 patients were randomized to receive either Contrave32 + BMOD or placebo + BMOD in a 3:1 ratio. Nine sites in the United States participated in the study.
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