Fast track for POI management drug
The FDA has designated Adolor Corporation's Entereg (alvimopan) as a Fast Track product for the management of postoperative ileus (POI).
The FDA has designated Adolor Corporation's Entereg (alvimopan) as a Fast Track product for the management of postoperative ileus (POI).
The FDA's notification of Fast Track designation indicated that postoperative ileus is a serious condition for which no drugs have been approved.
'Adolor and our collaborator for Entereg, GlaxoSmithKline, are dedicated to advancing the development of Entereg for the management of postoperative ileus and we are pleased that the FDA has granted it Fast Track designation,' said Bruce Peacock, president and ceo of Adolor Corporation. 'We are working diligently to submit an NDA for Entereg late in the first half of 2004.'
About Postoperative Ileus
Many patients undergoing open abdominal surgery experience temporary bowel impairment of variable duration. This phenomenon, known as postoperative ileus or POI, may be exacerbated and prolonged by multiple factors including the use of opioid analgesics for pain relief. POI is characterised by pain, abdominal distention or bloating, nausea and vomiting, accumulation of gas and fluids in the bowel, and delays in the passage of flatus or stool. There has been little advance in the treatment of POI since the introduction of nasogastric decompression, which has limited effectiveness and is uncomfortable for patients. There are no FDA-approved drugs for the management of POI currently available. There is a need for improved treatments because POI can have a negative impact on patient recovery and health care costs.