IRWD - AbbVie Ironwood constipation therapy Linzess meets main goal of phase 3 trial in children

AbbVie ( NYSE: ABBV ) and Ironwood Pharmaceuticals' medicine ( NASDAQ: IRWD ) Linzess met the main and secondary goals of a phase 3 trial in pediatric patients aged six years to 17 years with functional constipation (FC).

Linzess (linaclotide) is approved in the U.S. to treat adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) but not approved for use in patients less than 18 years of age.

The study, which included 330 patients, met its main and secondary goals by showing that linaclotide (72 mcg) improved frequency of spontaneous bowl movements (SBM) and stool consistency, the company said in a Sept. 6 press release.

Linaclotide showed a statistically significant  and clinically meaningful improvement compared to placebo in 12-week SBM frequency rate, the main goal.

Linaclotide-treated patients demonstrated a greater than two-fold least squares mean change from baseline in SBMs/week (2.220) compared to placebo.

Ironwood added that linaclotide was generally well-tolerated, and the safety profile was consistent with previously reported studies of the drug in FC and IBS in children.

The most frequently reported treatment-emergent adverse event was diarrhea, which occurred in 4.3% of linaclotide-treated patients, compared to 1.8% in the placebo group.

The companies will evaluate a potential supplemental New Drug Application (sNDA) submission for Linzess.

IRWD -4.55% to $10.39 premarket Sept. 6

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