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The Food and Drug Administration (FDA) has approved Linzess® (linaclotide) for the treatment of functional constipation (FC) in patients aged 6 to 17 years of age.
Approval was based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT04026113) that evaluated the efficacy and safety of linaclotide, a guanylate cyclase-C agonist, in 328 patients 6 to 17 years of age who met the modified Rome III criteria for child/adolescent FC. Patients were randomly assigned 1:1 to receive linaclotide 72mcg or placebo once daily for 12 weeks. The primary endpoint was the 12-week change from baseline in spontaneous bowel movement (SBM) frequency rate.
Results showed that patients in the linaclotide group had statistically significant improvements in SBM frequency compared with placebo (least squares 12-week mean change from baseline in SBM frequency rate: 2.6 vs 1.3, respectively; P <.0001). SBM frequency in the treatment group improved during week 1 and was maintained throughout the remainder of the 12-week treatment period.
The most common adverse reaction reported in pediatric patients 6 to 17 years of age with FC was diarrhea. Linaclotide carries a Boxed Warning concerning the risk of serious dehydration in patients less than 2 years of age and is contraindicated for this group.
The recommended dosage in pediatric patients with FC is 72mcg orally once daily. Linzess capsules can be opened and administered orally in either applesauce or with water for patients unable to swallow the capsule whole.
Linzess is also approved for the treatment of adults with irritable bowel syndrome with constipation and adults with chronic idiopathic constipation.
References:
- US Food and Drug Administration. FDA approves first treatment for pediatric functional constipation. News release. Accessed June 12, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-pediatric-functional-constipation.
- Ironwood Pharmaceuticals announces FDA approval of new indication for Linzess® (linaclotide) for the treatment of functional constipation in pediatric patients ages 6-17 years-old. News release. Ironwood Pharmaceuticals. June 13, 2023. https://www.businesswire.com/news/home/20230612173180/en/Ironwood-Pharmaceuticals-Announces-FDA-Approval-of-New-Indication-for-LINZESS%C2%AE-linaclotide-for-the-Treatment-of-Functional-Constipation-in-Pediatric-Patients-Ages-6-17-Years-Old
- Linzess. Package insert. AbbVie and Ironwood Pharmaceuticals. Accessed June 12, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf.
