There's more bad news for Wyeth and Progenics Pharmaceuticals for their late-stage drug Relistor. Researchers say the drug failed to hit a primary endpoint in restoring gastrointestinal function following surgery. Just as in another late-stage trial, preliminary data revealed no significant reduction in recovery time to a first bowel movement after surgery. Relistor won approval from the FDA for treating opioid-induced constipation. The companies say they'll study the data before deciding how to proceed with their research plans.
In a separate Phase II trial involving 122 patients with chronic, non-malignant pain who were receiving opioids for pain management, "the once daily oral formulation of Relistor showed statistically significant activity as assessed by the occurrence of spontaneous bowel movements and other efficacy measures."
Earlier this week Adolor and GSK won approval for Entereg for post-operative ileus, making it the only such drug on the market.
- read the press release
- here's the AP story