Ironwood Reports Positive Data From Phase 3 Trial Of LINZESS In Pediatric Patients With FC

(RTTNews) - Ironwood Pharmaceuticals Inc. (IRWD), on Tuesday, reported positive topline data from a Phase III clinical trial evaluating LINZESS (linaclotide) 72 mcg in pediatric patients aged 6-17 with functional constipation (FC).

The company stated that the trial met its primary and secondary endpoints, demonstrating that linaclotide (72 mcg) improved frequency of spontaneous bowl movements (SBM) and stool consistency. Linaclotide was generally well-tolerated, and the safety profile is consistent with previously reported studies with linaclotide in FC and irritable bowel syndrome (IBS) in pediatric patients.

Ironwood expects to share these Phase III trial data at upcoming scientific meetings and via peer-reviewed publications.

LINZESS is developed and marketed by Ironwood and AbbVie in the United States and is indicated for the treatment of adults with IBS-C or CIC. It is not approved for use in patients less than 18 years of age.