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Intravenous Form of Methylnaltrexone Gains Fast Track Designation
Methylnaltrexone is an investigational drug that is being studied as a treatment for the peripheral side effects of opioid analgesics that does not affect the pain relief provided by these analgesics. Methylnaltrexone is being developed in three dosage forms: subcutaneous and oral forms as treatment platforms for opioid-induced constipation, and an intravenous form for postoperative ileus. In December 2005, Wyeth and Progenics Pharmaceuticals entered into a collaboration agreement to develop and commercialize methylnaltrexone.
With Fast Track designation for methylnaltrexone for the treatment of postoperative ileus, the companies can take advantage of several programs at the FDA to streamline the regulatory review process and to work more closely with the Agency on product development plans. Sponsors of Fast Track products are also eligible to submit portions of a New Drug Application (NDA) on a rolling basis, enabling FDA to commence review of individual sections of the application before receiving the complete application. Additionally, the sponsors may request that methylnaltrexone be considered for priority review (six-month versus standard ten-month review).
Progenics Pharmaceuticals has completed a phase 2 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 3 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.
Source: Wyeth Pharmaceuticals and Progenics Pharmaceuticals