Wyeth, Progenics Get Fast Track

Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals have received Fast Track designation from the FDA for their application of the intravenous form of methylnaltrexone, which is being investigated for the treatment of postoperative ileus. 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. 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.

The Fast Track designation will allow the companies to submit the NDA on a rolling basis, and also to request priority review, cutting the review period from 10 months to six.

Progenics 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 in late 2007 or early 2008.