Ironwood Pharmaceuticals and Forest Laboratories announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of the investigational drug linaclotide in patients with chronic constipation (CC). Analyses of the data indicate that in both multicenter, randomized, double-blind, placebo-controlled trials, statistical significance was achieved for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder at the two doses studied in each trial (133 mcg/day: p-values ≤0.0012 and 266 mcg/day: p-values<0.0001). In both trials, statistical significance (p<0.01) was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs.
Linaclotide is an orally delivered peptide that acts locally in the gut with no detectable systemic exposure at therapeutic doses and is intended for once-daily administration. Linaclotide is an agonist of guanylate cyclase type-C (GC-C), a receptor found on the lining of the intestine. Activation of GC-C leads to increases in intracellular and extracellular cGMP.
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