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GSK and Adolor Announce Preliminary Results from Phase 3 Safety,Study of Alvimopan (Entereg/Entrareg)

n. This data is in contrast to previously conducted studies that showed a similar or lower incidence of fractures in patients receiving alvimopan relative to placebo.

Preliminary Conclusions and Next Steps

As the findings outlined were observed during the preliminary evaluation of data from Study 014, and a full analysis has not yet been completed, further details are not yet available. Additional data are being collected and further analyses, which will include all alvimopan OBD studies, will be undertaken as soon as possible to better understand these findings.

Pending completion of these analyses, the protocol for an additional Phase 3 safety and efficacy study in patients with OBD (Study 015), which had been submitted to regulatory authorities, is being withdrawn by GSK.

As a precautionary measure, GSK has taken the decision to stop Study 101684, an extension of Study 008 in a cancer pain population, which currently has 15 patients receiving treatment. Clinical investigators involved in this study have been informed.

"Patient well-being is always our primary concern. These unexpected findings are not yet fully understood and require further analyses to ascertain the significance of the data. We are working to gain a better understanding of these findings, which will help guide our future development," said Yvonne Greenstreet, Senior Vice President, Research and Development, GlaxoSmithKline.

Adolor has also suspended enrollment in Study 228 in rotator cuff surgery patients, a co-administration study being conducted as part of Adolor's Combination Product Development Program, until a more complete understanding of these data are available. Clinical investigators involved in these studies are being informed. GSK and Adolor currently have no other ongoing studies with alvimopan.

"We continue to believe in the clinical benefit of Entereg and look forward to the further analyses of these preliminary Study 014 results,"
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