Sucampo Pharma Americas reaped mixed late-stage results from two trials of its experimental opioid-induced bowel dysfunction drug. One study hit its primary endpoint but the other missed.
In study OBD0631, the primary endpoint of a statistically significant change from baseline in the frequency of spontaneous bowel movements at Week 8 of treatment was met when lubiprostone was compared to placebo. Statistical significance was also achieved for eight of the twelve secondary endpoints, including key symptoms associated with OBD. Study OBD0632 did not achieve statistical significance for the same primary endpoint.
But researchers are nevertheless feeling rather bullish about the results. Gayle Dolecek, senior vice president, research and development at Sucampo, said, "Given the results in the two studies, we are continuing further analysis of the data. However, these results suggest that lubiprostone may have the potential to treat the symptoms of OBD, for which there is currently no approved drug."
Sucampo expects more data from a follow-on study late this year, when it will decide how to proceed.
- check out the press release
- read the report from Reuters