Strong Ph III for Relistor in non-cancer OIC

The USA's Wyeth Pharmaceuticals and Progenics Pharmaceuticals say that a Phase III study of their Relistor (methylnaltrexone bromide) subcutaneous injection to treat opioid-induced constipation in patients with chronic, non-cancer pain achieved statistical significance for the primary and key secondary efficacy endpoints.

Adverse events observed in this study were similar to those seen in prior trials of subcutaneous Relistor. The positive outcome was from the double-blind, randomized, placebo-controlled portion of a Phase III study, the firms noted.

Wyeth and Progenics plan to meet with global regulatory agencies, including the US Food and Drug Administration, to review these data and intend to present results from both the double-blind and open-label phases of the study at an upcoming scientific meeting.