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Lubiprostone question - Vin      7-Nov-09 01:51 pm    
Vin,

I copy the following statements from Sucampo Pharma Americas Q3 release. Just wonder whether you have any thing to say about Lubiprostone as chronic pain OIDC.

http://www.drugs.com/sfx/lubiprostone-si...

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In July 2009, Sucampo Pharma Americas reported top-line results from two identically-designed phase 3 placebo-controlled pivotal clinical trials of lubiprostone (24 mcg, twice daily) for the management of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain. In one trial, the primary endpoint of a statistically significant change from baseline in the frequency of spontaneous bowel movements (SBMs) was met when lubiprostone was compared to placebo. The other trial did not achieve statistical significance for the same primary endpoint. In both trials, a post-hoc sub-analysis showed that subjects on methadone treatment regimens who were randomized to receive lubiprostone showed a lower SBM response when compared to lubiprostone subjects treated with other opioid medications. The fully-enrolled, long-term, follow-on, open-label safety study of lubiprostone in OBD subjects remains ongoing, and Sucampo continues to expect to report data from this study in late 2009. Sucampo anticipates submitting data from these trials to the FDA in 2010.
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Lubiprostone question - Vin
play_4_less Not rated 7-Nov-09 01:51 pm  
 
play, I have been a bit busy so didn't respond....
vinmantoo Rate it 19-Nov-09 01:02 am  
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