Ironwood Pharmaceuticals Inc (NASDAQ: IRWD) announced topline data from a Phase 3 trial evaluating Linzess (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation.
The trial met its primary and secondary endpoints, demonstrating that linaclotide (72 mcg) improved the frequency of spontaneous bowel movements (SBM) and stool consistency.
Linaclotide was generally well-tolerated, and the safety profile is consistent with previous studies.
In this study, 330 patients were randomized in a 1:1 ratio between linaclotide or placebo.
There are currently no FDA-approved pediatric therapies for Functional Constipation, affecting an estimated 4 to 6 million children ages 6 to 17 in the U.S.
The most frequently reported treatment-emergent adverse event was diarrhea, which occurred in 4.3% of linaclotide-treated participants versus 1.8% in the placebo group.
Linzess is developed and marketed by Ironwood and AbbVie Inc (NYSE: ABBV) in the U.S. and is indicated for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. It is not approved for use in patients less than 18 years of age.
Price Action: IRWD shares are up 1.10% at $11.00 during the premarket session on the last check Tuesday.
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