Wyeth and Progenics announce methylnaltrexone EMEA submission

Wyeth Pharmaceuticals and Progenics Pharmaceuticals have announced the submission of a subcutaneous formulation of methylnaltrexone as a treatment of opioid-induced constipation for marketing approval from the European Medicines Agency (EMEA).

This application is based on the result from two phase III clinical trials that attained their primary endpoints of efficacy and safety with the treatment well-tolerated by patients in most cases.

Methylnaltrexone is being developed in both orally-administered and subcutaneous injection formulations and aims to alleviate the effect of opioid on peripheral receptors in the body without affecting the pain relief provided to the central nervous system in these patients.

Progenics Pharmaceuticals has four products in clinical development and is currently developing methylnaltrexone as a treatment for a range of opioid-induced side effects in partnership with Wyeth.

Gary L Stiles, executive vice-president and chief medical officer of Wyeth Pharmaceuticals, said: “Methylnaltrexone has the potential to address a major gastrointestinal side effect of opioid therapy.”

He added that this application for marketing authorisation with the EMEA marks key progress in the development of the compound as a treatment for patients with opioid-induced constipation.

In October 2006, Wyeth Pharmaceuticals paid Progenics Pharmaceuticals a milestone payment of $5 million (2.64 million pounds) following the initiation of a late-stage trial by the firm into methylnaltrexone as a treatment for postoperative ileus.