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www.fdanews.com/articles/88416-wyeth-and-progenics-methylnaltrexone-receives-fast-track-designation

WYETH AND PROGENICS' METHYLNALTREXONE RECEIVES FAST-TRACK DESIGNATION

July 17, 2006

Wyeth Pharmaceuticals and Progenics Pharmaceuticals have announced that the intravenous form of methylnaltrexone being investigated for the treatment of postoperative ileus, a serious impairment of gastrointestinal function, has been granted fast-track status by 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.

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. The drug 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. Wyeth and Progenics entered into a collaboration agreement to develop and commercialize methylnaltrexone in December 2005.