Wyeth and Progenics start second phase III POI trial

Wyeth Pharmaceuticals and Progenics Pharmaceuticals have announced the start of a phase II clinical trial evaluating the efficacy and safety of intravenous administration of methylnaltrexone in patients with post-operative ileus (POI).

This is the second phase III clinical trial the companies have launched investigating this compound, the first being initiated in September 2006.

Methylnaltrexone is a mu-opoid receptor antagonist that aims to reverse the side effects that occur as a result of use of opioids, specifically in the gastrointestinal tract, without affecting pain-relief centred in the brain.

The company reports that POI can be worsened following the use of morphine and other opiod analgesics following operations, resulting in longer hospital stays and increased costs.

Previous clinical trials of the compound by Progenics showed that, following segmental colectomy, patients administered with methylnaltrexone showed improvements in clinically relevant measures of recovery.

“The primary efficacy endpoint is duration of POI as measured by time to first bowel movement,” Wyeth reports.

“The study will also examine safety and other secondary measures of GI recovery, including time to discharge eligibility,” it adds.

In August, Wyeth and Progenics launched a phase II clinical trial of the receptor antagonist for the treatment of POI.