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Alvimopan Receives Fast Track Status From FDA
The Fast Track Programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
"Adolor and our collaborator for Entereg(TM), GlaxoSmithKline, are dedicated to advancing the development of Entereg(TM) for the management of postoperative ileus and we are pleased that the FDA has granted Entereg(TM) Fast Track designation," said Bruce A. Peacock, president and chief executive officer of Adolor Corporation. "We are working diligently to submit an NDA for Entereg(TM) late in the first half of 2004."
About the FDA's Fast Track Program
In response to the requirements of the Food and Drug Modernization Act of 1997 the FDA issued guidance describing its policies and procedures pertaining to Fast Track products. The guidance indicates that a drug designated as a Fast Track product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address unmet medical needs for the condition. The Fast Track classification does not apply to a product alone, but applies to a combination of the product and specific indication for which it is being studied. In designating a Fast Track development program, the Agency will determine whether the drug has a potential to address unmet medical needs and whether the development program is designed to evaluate this potential.
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 characterized 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.
Source: Adolor Corporation