AbbVie (ABBV) announced Tuesday 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.
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.
CONSTELLA is also indicated for the treatment of adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).
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