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SEC Filings

S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 04/09/2007
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As noted, the p-values were statistically significant among all comparisons (intent-to-treat and completers) with the exception of a single comparison for the intent-to-treat population between 48mg naltrexone IR plus 400mg bupropion SR compared to 400 mg bupropion SR alone where the p-value was 0.0892. Weight loss through 48 weeks, plotted for the intent-to-treat and completer populations, is as follows:
 
Contrave Phase IIb Mean Weight Loss Over 48 Weeks
Intent-to-Treat Population
 
(GRAPH)
 
 
Contrave Phase IIb Mean Weight Loss Over 48 Weeks
Completer Population
 
(GRAPH)
 
As these results imply, most patients continued to lose weight between 24 weeks and 48 weeks. No serious adverse events related to Contrave’s bupropion/naltrexone combination occurred during this trial.
 
We will need to conduct additional clinical trials, the results of which may not corroborate our earlier results, in order to provide enough evidence regarding efficacy and safety to submit an NDA to the FDA for potential regulatory approval. In addition, undesirable side effects of Contrave may delay or prevent regulatory approval. The most common side effects observed in our clinical trials of Contrave to date include nausea, dizziness, insomnia and headaches.


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