AbbVie's CONSTELLA Receives Health Canada Approval for Treating Childhood Constipation

AbbVie (NYSE:ABBV), today announced that Health Canada has approved CONSTELLA® (linaclotide) as a once-daily oral treatment for children and adolescents 6 to 17 years of age with functional constipation. CONSTELLA is the first and only Health Canada-approved prescription therapy for functional constipation in this patient population.

Functional constipation is a chronic condition characterized by hard, infrequent bowel movements that are often difficult or painful to pass. Considered the most common functional gastrointestinal disorder in children, functional constipation has a pooled global prevalence of 14.4%.2 Core symptoms of functional constipation include decreased stool frequency, harder stool consistency, painful passage of stools, and fecal incontinence.

The approval of CONSTELLA is based on efficacy and safety results from a Phase 3 clinical trial, which met the primary endpoint evaluating linaclotide (72 mcg) for increased frequency of spontaneous bowel movements (SBM) in patients aged 6 to 17 years.