GSK and Adolor update Entereg development programme

GlaxoSmithKline (GSK) and Adolor have announced an update to the development programme for Entereg (alvimopan).

Included in this update are the final results of study 101684 – a continuation of a phase IIb clinical trial of alvimopan as a treatment for opioid-induced bowel dysfunction in cancer pain patients – in addition to the results from study 014 and data from a two-year carcinogenity study in rodents.

This information issued in response to a request for additional data from the US Food and Drug Administration, which has also requested information from study 228, a trial co-administered by Adolor, which has since halted the study in order to collect final data.

Michael R Dougherty, president and chief executive officer of Adolor, said: “We are working closely with GSK to complete analyses of these studies and satisfy all requests for data for our complete response.”

He added that the company expected that a submission would be made to the FDA at some point in the third quarter of the year.

In April 2007, GSK announced the preliminary results of a phase III clinical trial assessing the use of Entereg in non-chronic cancer patients suffering from opioid-induced bowel dysfunction.

The company reported “unexpected findings” in the trial which would require further analysis in order to ascertain its significance.