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news.Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals, a biopharmaceutical company, have announced that a Phase III clinical study investigating Relistor 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.
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Adverse events observed in this study were similar to those seen in prior studies of subcutaneous Relistor. The positive outcome reported was from the double-blind, randomized placebo-controlled portion of a Phase III clinical study.
In the double-blind phase of this study, in which Relistor or placebo were administered subcutaneously for four weeks, the endpoints included the proportion of Relistor injections resulting in bowel movements within four hours and the evaluation of the number of bowel movements per week.
Wyeth and Progenics plan to meet with global regulatory agencies, including the FDA, to review these data and intend to report results from both the double-blind and open-label phases later.
Gary Stiles, chief medical officer of Wyeth Pharmaceuticals, said: “Many patients who take prescription opioids to help relieve their non-cancer pain experience opioid-induced constipation (OIC), which can disrupt their lives. The results of this study suggest that Relistor has the potential to help decrease the constipating effects of opioids for this patient population.”