FDA GRANTS PROGENICS AND WYETH'S DRUG FAST-TRACK STATUS

The FDA has given fast-track status to a post-surgical drug being developed by Wyeth Pharmaceuticals and Progenics Pharmaceuticals, the companies said July 17.

The drug is an intravenous form of methylnaltrexone being investigated as a potential treatment for postoperative ileus, an impairment of gastrointestinal function that delays recovery from surgery and prolongs hospitalization.

Under fast-track status, the FDA allows companies to submit clinical trial data on a rolling basis instead of submitting a comprehensive one-time application. It is intended for drugs that that treat serious diseases for which there is an unmet medical need.

The two companies have plans to submit a new drug application for the intravenous form of methylnaltexone in late 2007 or early 2008.