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Orexigen reports statistically significant results from phase IIb trial of Empatic (obesity)
Tuesday, July 24, 2007

OREX says the trial demonstrated, across each of the six Empatic treatment arms, statistically significant weight loss against placebo (p less than .001). The trial tested various ratios of bupropion and zonisamide in 620 patients. At the highest dose tested, patients experienced 8.6% weight loss from baseline compared to 1.1% weight loss for placebo in the intent-to-treat group, and 10.3% weight loss from baseline compared to 1.2% weight loss for placebo in the completer group. The trajectory of weight loss for all treatment groups appeared to continue downward through 24 weeks. The pooled discontinuation rate due to adverse events, across the six Empatic dosage groups, was not statistically different than the rate seen with placebo. Additional safety and efficacy data will be reported following completion of an ongoing 24-week trial extension. A detailed presentation of the primary trial results is scheduled to be presented at the 2007 meeting of the North American Association for the Study of Obesity (NAASO), to be held October 20-24 in New Orleans.  



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