GSK holds on to license covering postoperative ileus, for which Entereg is already approved.

GlaxoSmithKline returned worldwide rights covering the development of Entereg® for chronic opioid bowel dysfunction (OBD) to Adolor. The compound had reached Phase III trials.

GSK also returned rights related to Entereg for irritable bowel syndrome and nonopioid induced forms of constipation or bowel dysfunction. There have been no active development programs for these indications.

GSK does, however, retain rights to Entereg for postoperative ileus (POI), which recently won FDA approval. The companies will continue to collaborate on commercialization of Entereg for POI in the U.S.

Adolor announced in July that the FDA lifted the clinical hold on the IND application for Entereg in OBD

“We intend now to submit to the FDA for review a protocol for an additional study of Entereg in OBD under a special protocol assessment,” says Michael R. Dougherty, president and CEO of Adolor. 

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