GSK ‘continuing to work on POI programmes’

GlaxoSmithKline (GSK) and Adolor have reported that they are committed to bringing Entereg (alvimopan) to market as a treatment for the management of postoperative ileus (POI).

The firm has made this announcement following the decision by the US Food and Drug Administration to accept the response from Adolor to its approvable letter for the new drug application for the compound made in November 2006.

Adolor has been informed by the regulator that its response has been considered as a complete class two response with a goal date for the Prescription Drug User Fee Act of February 10th 2008.

Yvonne Greenstreet, senior vice-president of the medicines development centre at GSK, said: “GSK has conducted analyses to fully understand the findings from the OBD programme and believe these support the initial step of submitting the request to release the clinical hold.”

She added that the company is continuing to work with both the regulatory authorities and its partner Adolor on opioid-induced bowel dysfunction and their POI programmes.

In June 2007, GSK and Adolor announced an update to their development programme for Entereg, including the final results of a continuation phase IIb study assessing the use of the compound as a treatment for opioid-induced bowel dysfunction in cancer pain patients.