Wyeth, Progenics: Methylnaltrexone receives fast-track status for treatment of postoperative ileus

By E. Janene Geiss

Philadelphia, July 17 - Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals, Inc. announced Monday that the intravenous form of methylnaltrexone being investigated for the treatment of postoperative ileus, a serious impairment of gastrointestinal function that delays recovery and can prolong hospitalization, has been designated for fast-track status by the Food and Drug Administration.

The fast-track designation speeds 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, according to a company news release.

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 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, officials said.

Sponsors of fast-track products also are eligible to submit portions of a New Drug Application on a rolling basis, enabling FDA to begin review of individual sections of the application before receiving the complete application.

Additionally, the sponsors may request that methylnaltrexone be considered for priority review, which is a six-month versus standard 10-month review, officials said.

Progenics has completed a phase 2 study of intravenous methylnaltrexone showing accelerated gastrointestinal recovery in patients following segmental colectomies.

In the third quarter, Wyeth and Progenics said they plan to begin 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, officials said.

Wyeth is a Madison, N.J., pharmaceutical company.

Progenics is a Tarrytown, N.Y., biopharmaceutical company.

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