FDA Opts To Fast Track Constipation Drug

Law360, New York (July 17, 2006, 12:00 AM EDT) -- Trying to accelerate the regulatory review process, the U.S. Food and Drug Administration has decided to fast-track Wyeth Pharmaceuticals and Progenics Pharmaceuticals’ application for a drug intended to treat postoperative gastrointestinal impairment.

The FDA announced the move on Monday, revealing that it has awarded fast-track status to the intravenous form of methylnaltrexone, which would be used to minister to the postoperative ileus (POI) condition.

POI is an impairment of bowel motility that usually occurs after abdominal surgery.

The average duration of ileus after major abdominal surgery...
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