The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for linaclotide for the treatment of pediatric patients 6 to 17 years of age with functional constipation.
The application was supported by data from a multicenter, randomized, double-blind, parallel-group phase 3 trial (ClinicalTrials.gov Identifier: NCT04026113) that evaluated the efficacy and safety of linaclotide, a guanylate cyclase-C agonist, in 330 patients 6 to 17 years of age who fulfilled modified Rome III Criteria for child/adolescent functional constipation. Patients were randomly assigned 1:1 to receive either linaclotide 72mcg orally once daily or placebo.
Trial results showed that treatment with linaclotide met the primary endpoint demonstrating a statistically significant and clinically meaningful improvement in the 12-week SBM (spontaneous bowel movement) frequency rate (SBMs/week) compared with placebo. Moreover, an improvement in stool consistency was observed with linaclotide vs placebo, as assessed by Bristol Stool Form Scale scores (secondary endpoint). The most frequently reported treatment-emergent adverse event was diarrhea.
“Pediatric functional constipation has a significant impact on young patients and their families, yet there are no FDA-approved prescription therapies available for this population,” said Michael Shetzline, MD, PhD, chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “We welcome the FDA’s decision to grant priority review, as it brings us even closer to potentially changing the treatment landscape for pediatric patients ages 6-17 years-old with this condition.”
A Prescription Drug User Fee Act target date of June 14, 2023 has been set for the application.
Linaclotide is currently marketed under the brand name Linzess for the treatment of adults 18 years of age and older with irritable bowel syndrome with constipation or chronic idiopathic constipation.
Ironwood Pharmaceuticals announces FDA filing acceptance and Priority Review of supplemental New Drug Application for Linzess® (linaclotide) for functional constipation in children and adolescents ages 6-17 years-old. News release. Ironwood Pharmaceuticals. Accessed February 13, 2023. https://www.businesswire.com/news/home/20230213005077/en/Ironwood-Pharmaceuticals-Announces-FDA-Filing-Acceptance-and-Priority-Review-of-Supplemental-New-Drug-Application-for-LINZESS%C2%AE-linaclotide-for-Functional-Constipation-in-Children-and-Adolescents-Ages-6-17-Years-Old.