The USFDAhas granted Fast Track designation to an intravenuous form of methylnaltrexone for the treatment of post-operative ileus, a gastrointestinal condition that delays recovery and prolongs hospitalization.
Methylnaltrexone is an investigational drug for the treatment of the peripheral side effects of opioid analgesics, and is being developed in subcutaneous, oral, and intravenuous forms. The intravenuous form is jointly being developed by Wyeth Pharmaceuticals and Progenics Pharmaceuticals, Inc.
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.
Wyeth and Progenics plan on initiating a global Phase III clinical trial of intravenous methylnaltrexone soon, and an NDA submission is projected in late 2007 or 2008.
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