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SEC Filings

S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
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* Calculated on the basis of adjusted least-squares mean methodology.
 
  (1)  Placebo and bupropion monotherapy groups represent patients from our Contrave Phase II clinical trial, which we consider comparative due to the similarity of clinical trial protocols and overlapping clinical trial sites. Placebo data represents results at 16 weeks, as the placebo arm was discontinued at that point.
 
 
The p-values for the 24 week intent-to-treat data were 0.005 and 0.10 for the Excalia combination against bupropion and zonisamide monotherapies, respectively. For the 24 week completer data, the p-values were 0.00006 and 0.024 for the Excalia combination against bupropion and zonisamide monotherapies, respectively. We have ascribed no p-value for the Excalia combination against placebo for either the intent-to-treat or the completer populations since, as described in footnote 1 above, the placebo data used in the Excalia trial came from our Contrave Phase II trial and represented 16 week results.
 
Weight loss, plotted over time for the intent-to-treat and completer populations, was as follows:
 
Excalia Phase II Mean Weight Loss Over 24 Weeks
Intent-to-Treat Analysis
 
(GRAPH)
 
Excalia Mean Weight Loss Over 24 Weeks
Phase II Completer Analysis
 
(GRAPH)


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