Good Ph III data for Adolor/GSK's Entereg

The USA's Adolor and UK drug major GlaxoSmithKline have released encouraging initial top-line results from the Phase III Study 14CL314 of their co-developed drug candidate Entereg (alvimopan) for the management of postoperative ileus following bowel resection surgery. The 654-patient evaluation showed that a 12mg dose of Entereg achieved a statistically-significant difference compared to placebo for the primary endpoint of time-to-recovery of GI function. The secondary endpoint, time-to-discharge order written, was approximately 18 hours sooner for Entereg patients than those on placebo, which also reached statistical significance. The firms noted that this data should satisfy the conditions of the US Food and Drug Administration's July 2005 approvable letter and Adolor says it will use the final results from the trial as part of a complete response to be submitted in June.