FDA Approval Sought for Drug to Treat Chronic Constipation

Linaclotide is an investigational drug designed to treat patients with constipation by stimulating intestinal secretion of chloride, bicarbonate, and fluid and by increasing intestinal transit. In two manufacturer-sponsored randomized trials, nearly 1300 patients with chronic constipation (defined as fewer than 3 spontaneous bowel movements weekly, plus symptoms such as hard stools or straining) received linaclotide or placebo.

The primary endpoint was three or more complete spontaneous bowel movements (CSBMs) weekly, plus an increase of at least one CSBM above baseline. During 12 weeks of treatment, linaclotide recipients were significantly more likely than placebo recipients to reach this endpoint (about 20% vs. 5%). The mean frequency of …