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news.The FDA has granted fast track status to Wyeth Pharmaceuticals and Progenics Pharmaceuticals' intravenous form of methylnaltrexone being investigated for the treatment of postoperative ileus.
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In December 2005, Wyeth and Progenics Pharmaceuticals entered into a collaboration agreement to develop and commercialize methylnaltrexone.
The FDA fast track designation facilitates development and expedites regulatory review of drugs that the FDA recognizes to potentially address an unmet medical need for serious or life-threatening conditions.
Progenics Pharmaceuticals has completed a phase II study of intravenous methylnaltrexone showing accelerated gastrointestinal recovery in patients following segmental colectomies.
In the 2006 third quarter, Wyeth and Progenics plan to initiate global phase III studies in patients at high risk for developing postoperative ileus. An NDA submission is planned for the intravenous form of methylnaltrexone in late 2007 or early 2008.
Postoperative ileus is a major contributor to prolonged hospital stays and has an impact on health care costs. Because many postoperative patients cannot tolerate oral intake, including medications, intravenous methylnaltrexone may represent an important therapy for these patients.