Results from the three other Phase 3 trials (NB-301, NB-303, NB-304) are expected to be announced in the third quarter of 2009. Pending positive results, the Company is on track to submit a New Drug Application (NDA) with the FDA in the first half of 2010.
NB-302 was a 56-week, double-blind, placebo-controlled trial, conducted in 793 patients at nine U.S. centers. The trial evaluated the additional weight loss of Contrave (32mg naltrexone SR/360mg bupropion SR) when added to an intensive behavior modification program consisting of counseling, diet and exercise. The co-primary endpoints were percent change in total body weight from baseline and proportion of patients who lost at least 5% of their baseline body weight.
Based on pre-specified intent-to-treat and completer analyses, obese patients treated with Contrave lost an average of 20.3 pounds to 25.0 pounds, or 9.3% to 11.5% of their baseline body weight, versus 11.0 pounds to 16.0 pounds, or 5.1% to 7.3% of baseline body weight, for patients treated with placebo. In addition, in the categorical weight reduction analysis, the percentage of patients who lost greater than or equal to 10% of their body weight was 41.5% in the Contrave group, compared to 20.2% in the placebo group. Furthermore, 29.1% of patients lost greater than or equal to 15% of their body weight in the Contrave group; compared to 10.9% in the placebo group. All of these findings were highly statistically significant (p< 0.001).
"NB-302 demonstrates that Contrave delivers greater weight loss to patients when added to a rigorous behavioral intervention program compared to the intervention program alone, underscoring the important role of pharmacotherapy as part of a weight management program," said Michael Narachi, President and Chief Executive Officer, Orexigen Therapeutics. "These data
|SOURCE Orexigen Therapeutics, Inc.|
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