New drug might help treat irritable bowel syndrome

September 18, 2012 by Amanda Gardner, Healthday Reporter
New drug might help treat irritable bowel syndrome
Maker-funded studies found reduction in symptoms such as abdominal pain.

(HealthDay)—A new drug significantly reduces the abdominal pain and constipation characteristic of certain types of irritable bowel syndrome, according to two new studies.

Both trials, published online Sept. 18 in the , formed much of the basis for approval of the drug, Linzess (linaclotide), by the U.S. 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 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 with , over-the-counter medications or , he added.

The trial led by Chey involved 804 adults, mostly women, who were randomly assigned to receive 290 of Linzess or an inactive placebo once a day for six months.

Several outcomes were measured but the most rigorous was one stipulated by the FDA: that the patient reported an improvement of at least 30 percent in abdominal pain and an increase of at least one bowel movement each week for six to 12 weeks, among other gauges.

About one-third of participants taking Linzess experienced the FDA-specified improvements, including less pain and increased bowel movements, versus 14 percent of those in the placebo group, the investigators found.

On average, participants reported about 43 percent improvement in abdominal pain by the end of the treatment period, along with easing of other symptoms such as cramping and bloating. The improvements started almost right away.

The second trial looked at 800 patients randomly assigned to the same dose of Linzess or a placebo, this time for 12 weeks. Again, about one-third of patients taking Linzess reported improvements in pain and constipation versus 21 percent in the placebo group.

When patients were later switched from linaclotide to a placebo, their symptoms returned, the researchers found.

The main side effect was , the study authors, led by Dr. Satish Rao, of Georgia Health Sciences University in Augusta, noted in the report.

Linzess is believed to work by stimulating the secretion of chloride and water in the intestine. This helps soften the stool and stimulate contractions that can lead to bowel movements, Chey explained.

Commenting on the research, Dr. Timothy Pfanner, a gastroenterologist and assistant professor of internal medicine at Texas A&M Health Science Center College of Medicine, said: "This is a really interesting drug in that it works differently than anything else we have. It basically acts on some nerve receptors and stimulates them to inhibit the pain response and reduces bloating and increases motility," he added.

"There are lots of drugs out there for constipation," Pfanner noted. "What makes this different is it may actually help with the irritable bowel-type symptoms, particularly bloating and pain. That's a real advantage."

Unlike inflammatory bowel disease—which includes Crohn's disease and ulcerative colitis—biopsies reveal no abnormalities in the colons of people with . In inflammatory bowel disease, biopsies show "all kinds of inflammation," Pfanner said. "The colon looks angry and red and swollen."

Although a price hasn't been set for Linzess, a similar existing costs patients roughly $200 to $300 per month.

Explore further: New drug approved for irritable bowel, chronic constipation

More information: The U.S. National Library of Medicine has more about irritable bowel syndrome.


Related Stories

New drug approved for irritable bowel, chronic constipation

August 30, 2012

(HealthDay)—Linzess (linaclotide) has been approved by the U.S. Food and Drug Administration to treat forms of chronic constipation that don't respond to traditional treatment, and irritable bowel syndrome accompanied by ...

Recommended for you

Bile acid uptake inhibitor prevents NASH / fatty liver in mice

September 21, 2016

Drugs that interfere with bile acid recycling can prevent several aspects of NASH (nonalcoholic steatohepatitis) in mice fed a high-fat diet, scientists from Emory University School of Medicine and Children's Healthcare of ...

New therapeutic target for Crohn's disease

September 20, 2016

Research from the Sanford Burnham Prebys Medical Discovery Institute (SBP) identifies a promising new target for future drugs to treat inflammatory bowel disease (IBD). The study, published today in Cell Reports, also indicates ...

Mosquitoes, Zika and biotech regulation

September 19, 2016

In a new Policy Forum article in Science, NC State professor Jennifer Kuzma argues that federal authorities are missing an opportunity to revise outdated regulatory processes not fit for modern innovations in biotechnology, ...

Arthritis drug may help with type of hair loss

September 22, 2016

(HealthDay)—For people who suffer from a condition that causes disfiguring hair loss, a drug used for rheumatoid arthritis might regrow their hair, a new, small study suggests.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.