Entereg developed by GlaxoSmithKline is used for the management of postoperative ileus (POI) by accelerating time to recovery of gastrointestinal (GI) function subsequent to abdominal or pelvic surgeries. POI is a temporary impairment of GI function that can occur following many types of surgery. GlaxoSmithKline and Adolor are collaborating on the worldwide growth and commercialization of Entereg.

The FDA granted Fast Track designation to Entereg for use in the management of POI, representing that POI is a serious medical condition and that there are no drugs currently approved for this condition. This is an FDA program available to drug candidates that have received Fast Track designation and allow for completed portions of an NDA to be submitted on an ongoing basis.

Many patients undergoing abdominal surgery experience brief gastrointestinal impairment. This condition, called as postoperative ileus, may be exacerbated and prolonged by multiple factors including the use of opioid analgesics for pain relief. Abdominal distension and pain, reduced desire to eat, nausea and vomiting, and an inability to pass gas or stool characterize POI. POI is a key contributor to prolonged hospital stays. Therefore, POI represents a substantial burden on healthcare resources. Inspite of the negative impact, there have been few advances in the treatment of POI since the introduction of nasogastric decompression over 100 years ago, which has limited effectiveness and is uncomfortable for patients. At present, there are no drugs approved for the management of POI.

Adolor Corporation and GlaxoSmithKline are on the massive expansion of promoting Entereg for POI, opioid-induced bowel dysfunction (OBD) associated with extended use of opioids to manage cancer pain or chronic non-cancer pain, chronic constipation not associated with opioid use, and irritable bowel syndrome (constipation predominant).