RALEIGH, N.C. (AP) – Salix Pharmaceuticals and Progenics Pharmaceuticals said a late-stage study for an expanded use of the constipation treatment Relistor yielded positive results.
The trial evaluated the safety and effectiveness of once-daily oral doses of the drug compared to a placebo in treating opioid-induced constipation in patients with chronic pain not related to cancer, the companies said.
Both 300 milligram and 450 milligram doses showed “highly statistically significant” improvements in patients compared to a placebo, the companies said.
Relistor already is approved in an injectable form to treat opioid-induced constipation in patients with advanced illnesses who are receiving palliative care. The expanded use would be for patients who have chronic pain like back or joint pain.
The companies also are seeking approval from the Food and Drug Administration to market the injectable version of the drug for patients with chronic, non-cancer pain.
Opioid-induced constipation is caused by opioids like forms of the painkiller morphine.
Progenics, based in Tarrytown, N.Y., developed Relistor in collaboration with Wyeth. Progenics regained the rights after Wyeth was sold to Pfizer Inc., the world’s largest drugmaker, in 2009. It then entered into a sales and development agreement last February with Raleigh, N.C.- based Salix.
Date: December 20, 2011
Source: Associated Press
