Ironwood and Forest announced that the FDA has approved Linzess (linaclotide; Ironwood and Forest) capsules for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
The approval for the management of IBS-C was established in two, Phase 3 double-blind studies. Patients (n=1,604) were randomized to Linzess 290mcg or placebo for >12 weeks. Study results showed that Linzess was more effective in reducing the amount of abdominal pain and increasing the number of complete spontaneous bowel movements compared with placebo.
The approval for management of chronic idiopathic constipation was also established in two, double-blind studies. In this study, a total of 1,272 patients were randomized to Linzess 145mcg or 290mcg or placebo for 12 weeks. Study results showed that patients taking Linzess experienced more complete spontaneous bowel movements than those taking the placebo. The 290mcg dose is not approved for chronic constipation because studies indicated it was no more effective than the 145mcg dose.
Linaclotide, a guanylate cyclase-C (GC-C) agonist, acts locally in the intestine with minimal systemic exposure. It helps relieve constipation by helping bowel movements occur more often. In IBS-C, it may also help ease abdominal pain. Ironwood and Forest expect Linzess to be available in the fourth quarter of 2012
For more information call (617) 621-7722 or visit www.ironwoodpharma.com.