Drugs Ease Hard-to-Treat Constipation
Results of Resolor Study Are Positive; Relistor Helps Opioid Constipation
May 28, 2008 -- Results only now reported from a 12-week clinical trial that ended nine years ago suggest that a new drug, Resolor, helps people with chronic constipation.
Meanwhile, promising findings suggest that a new form of naltrexone, a drug used to block the narcotic effects of opioids in addicts, may relieve the terrible constipation that afflicts patients who need opioids to control their pain.
The Resolor results appeared only after Johnson & Johnson, which developed the drug, licensed it to the Belgian firm Movetis NV.
Late or not, the results may be good news to the estimated 15% of Americans who suffer the straining, bloating, and abdominal discomfort of chronic constipation.
Resolor "significantly increased the number of spontaneous, complete bowel movements, reduced the severity of symptoms, and improved the disease-related quality of life in patients with severe chronic constipation," report Mayo Clinic researcher Michael Camilleri, MD, and his Movetis colleagues.
Nearly half of the patients receiving Resolor, but only a fourth of the patients receiving an inactive placebo, averaged at least one complete bowel movement per week.
None of the patients showed signs of heart problems. That's good news, but there's reason to need more safety data, says Arthur J. Moss, MD, of the University of Rochester in New York. Moss' editorial accompanies the Camilleri report in the May 29 issue of The New England Journal of Medicine.
Resolor is in the same drug family as Propulsid and Zelnorm, both of which were taken off the market because they caused dangerous heart problems in some patients. Zelnorm returned to the market with a dire warning on its label, but was then voluntarily removed from the market by the manufacturer.
"It is not clear why clinical trials with [Resolor] were temporarily suspended around 2001 or why it took so long to bring this study to publication," Moss notes. "We simply do not know whether the drug will [cause serious heart problems] in a small fraction of vulnerable subjects with a non-life-threatening gastrointestinal disorder."
Moss says more complete data will be needed before the drug should be brought to market as a treatment for chronic constipation.