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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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