Constipation drug effective, study suggests
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Progenics Pharmaceuticals Inc. and Wyeth said on Tuesday that their experimental treatment for constipation caused by opioid painkillers proved effective in a late-stage clinical trial.
The 133-patient study is the second pivotal-stage trial of the subcutaneous drug, called methylnaltrexone, in patients with painful, terminal illnesses, such as cancer and heart disease, who also suffer from constipation.
The study showed that 48 percent of severely constipated patients experienced a bowel movement within four hours of receiving their first dose of the drug, compared with 16 percent given a placebo. More than 70 percent of methylnaltrexone patients responded by the end of the first week of treatment.
Opioids such as morphine are widely used to lessen the suffering of the approximately 1.7 million Americans living with painful terminal illnesses. They block the perception of pain within the central nervous system, but also interact with receptors outside the brain and spinal cord, resulting in constipation and other side effects.
Methylnaltrexone is designed to block the effect of the painkillers on opioid receptors outside the central nervous system.
For those who responded in the trial, the median time to laxation was 30 minutes, and there were no reports of diminished pain relief.
The most common side effect was temporary abdominal cramping.
The data, presented here at the Digestive Disease Week annual meeting, confirm the results of the single-dose trial and show that the drug can work well over a two-week period, said Dr. Neil Slatkin, study investigator and director of the department of supportive care, pain and palliative medicine at City of Hope cancer center in Duarte, California.
“These patients are the sickest of the sick. Everything had been tried without success,” he said.
Progenics and Wyeth plan to file for U.S. Food and Drug Administration approval of the drug early next year, by which time they expect to have an improved formulation that does not need to be refrigerated.
The companies will not need to conduct further human clinical trials of the more convenient, room-temperature formulation, said Dr. Robert Israel, senior vice president of medical affairs at Progenics.
Progenics in December reached a deal worth up to $416.5 million with Wyeth to develop and market the drug.
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