Linaclotide

Linaclotide Shows Promise as a Treatment for Patients with IBS with Constipation

November 2009 – Linaclotide™ is a promising, first-in-class drug for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. It is now in Phase 3 clinical development.

At therapeutic doses, linaclotide acts locally in the gut. Exposure in the body outside the gut has not been detected. The drug is taken orally once daily.

In previous, Phase 2, trials patients taking linaclotide experienced statistically significant improvement in multiple symptoms. Over a 12-week treatment period, patients with IBS-C reported reduced abdominal pain, discomfort, and bloating, as well as improved bowel function. Over a 4-week treatment period, patients with chronic constipation reported reduced constipation, abdominal discomfort, and bloating.

No serious side effects related to treatment were reported in the trials. Diarrhea was the most commonly reported side effect in both groups.

Phase 3 clinical trials involve studies of people to confirm a drug’s safety and effectiveness. Appropriate regulatory agencies review trial results for approval before the drug can be prescribed.

In the United States, linaclotide is being developed collaboratively by Forest Laboratories, Inc. and Ironwood Pharmaceuticals, Inc.