The FDA's gastrointestinal drug advisory committee narrowly endorsed Entereg, a new drug for postoperative ileus in bowel resection. The vote came down 9 to 6 in Entereg's favor. The FDA is considering an NDA for the drug, which is being developed by Adolor and GlaxoSmithKline. There are currently no drugs approved for this indication.
"A majority of the committee agreed that Entereg produced clinically meaningful acceleration in [gastrointestinal] recovery in bowel resection patients," said Yvonne Greenstreet, senior vice president of the medicine development center at Glaxo, in a statement. "Postoperative ileus can be uncomfortable for the patient, hinder post surgical recovery and delay hospital discharge in bowel resection patients."
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