New drug shows promise in treating symptoms of irritable bowel syndrome

The colon – also called the large intestine or large bowel – consists of the last five feet of the digestive tract. Its main function is to conduct indigestible portions of food, or waste material, out of the body. Any disruption of this function can lead to a change in bowel activity – to diarrhea or constipation – and abdominal pain. When all other diseases that may reasonably cause the same symptoms have been excluded, individuals suffering from recurring attacks of abdominal pain, diarrhea and constipation are diagnosed with irritable bowel syndrome.

Irritable bowel syndrome (IBS), also known as spastic colon, mucus colitis and a variety of other names, is a common gastrointestinal disorder that is uncomfortable but not serious. About a third of those diagnosed with IBS suffer from constipation, a condition that occurs more commonly in women than in men and often includes additional symptoms, such as abdominal bloating, hard stools, straining and a sensation of incomplete evacuation.

However, there is good news for individuals suffering from irritable bowel syndrome with constipation.

Two recent phase 3 trials, published online Sept. 18 in the American Journal of Gastroenterology, helped pave the way for FDA approval of Linzess (linaclotide), a drug designed for patients who have irritable bowel syndrome with constipation. Phase 3 trials are the final step before applying for New Drug Approval from the FDA. Both trials included approximately 800 adult patients, mostly women, who were randomly assigned to receive the prescription drug linaclotide or a placebo. One trial covered a 26-week period; the other included a 12-week trial period and four-week randomized withdrawal period.

In both studies, patients taking linaclotide reported significantly greater percentages of improvement in abdominal and bowel symptoms compared with those on placebo treatment; both groups experienced relief of symptoms within one week of therapy. Researchers also found that when patients were switched from linaclotide to a placebo, their symptoms returned.

Until now, far too many patients suffering from IBS with constipation have accepted abdominal pain, as well as other common IBS symptoms such as abdominal bloating and discomfort, as a way of life. Linaclotide shows great promise in relieving these symptoms and restoring qualify of life for these individuals.

If you have IBS, talk to your GIA gastroenterologist about which treatment is right for you.