TUESDAY, Sept. 18 (HealthDay News) -- A new drug significantly reduces the abdominal pain and constipation characteristic of certain types of irritable bowel syndrome, according to two new studies.
Both phase 3 trials, published online Sept. 18 in the American Journal of Gastroenterology, formed much of the basis for approval of the drug, Linzess (linaclotide), by the U.S. Food and Drug Administration in August, said Dr. William Chey, lead author of one of the studies and co-editor-in-chief of the journal.
"These are as good a set of results as we've seen on a drug for patients with constipation-predominant irritable bowel syndrome," said Chey, who is a professor of medicine at the University of Michigan Health System, in Ann Arbor.
Both trials were funded by Forest Research Institute and Ironwood Pharmaceuticals, Inc., which make the drug. An Ironwood employee provided editorial assistance for both studies.
Irritable bowel syndrome is a difficult-to-diagnose and difficult-to-treat condition that can have paradoxically opposite symptoms.
Although patients with irritable bowel syndrome universally complain of abdominal pain and discomfort, this can be due either to diarrhea or constipation or a combination, Chey said.
No one knows exactly what causes the condition (and it may be more than one condition) so a diagnosis is made based on symptoms.
Until the approval of Linzess, only two drugs were approved for the condition, one for constipation-predominant irritable bowel syndrome and one for diarrhea-predominant irritable bowel syndrome, Chey said.
And roughly half of patients don't have adequate symptom relief with prescription drugs, over-the-counter medications or dietary changes, he added.
The trial led by Chey involved 804 adults, mostly women, who were randomly assigned to receive 290 micrograms of Linzess or an inactive
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