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If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.
AbbVie has submitted to the FDA a supplemental new drug application (sNDA) for Linzess (linaclotide) to treat children and adolescents 6 to 17 years of age with functional constipation (FC). Linzess is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated to treat adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C).
"Although functional constipation is common among pediatric patients, it has long been difficult to manage due to a lack of approved prescription treatment options," Celine Goldberger, M.D., Ph.D., vice president, head of US medical affairs, AbbVie, said in a press release.
Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass. It is a common problem in children of all ages, with a worldwide prevalence ranging between 0.7% and 29.6%.
The sNDA submission is based on results from a phase 3 clinical trial, which met the primary and secondary endpoints, evaluating Linzess (72 mcg) for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in patients aged 6 to17 years. A total of 330 patients were randomized to Linzess or placebo. Linzess showed a statistically significant and clinically meaningful improvement compared with placebo in 12-week SBM frequency rate (SBMs/week), the primary endpoint. The most common adverse event in the study was diarrhea, which occurred in 4.3% of Linzess-treated patients versus 1.8% in the placebo group.