AbbVie has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) FDA to treat children and adolescents 6 to 17 years of age with functional constipation (FC). The sNDA submission is based on results from a Phase 3 clinical trial, which met the primary and secondary endpoints, evaluating linaclotide (72 mcg) for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in patients aged 6 to17 years. LINZESS is developed and marketed by AbbVie and Ironwood Pharmaceuticals in the United States and is currently indicated for the treatment of 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," said Celine Goldberger, MD, PhD, vice president, head of US medical affairs, AbbVie. "This milestone demonstrates our tireless work to advance the standards of care in order to make a difference in patients' lives."
In the multicenter double-blind Phase 3 study evaluating LINZESS in patients 6 to 17 years of age with functional constipation, a total of 330 patients were randomized in a 1:1 ratio between linaclotide or placebo. Linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week SBM frequency rate (SBMs/week), the primary endpoint. Linaclotide-treated patients demonstrated a greater than two-fold least squares mean change from baseline in SBMs/week (2.220) compared to placebo (1.050) (p<0.0001).
The Phase 3 study demonstrated acceptable safety in the pediatric population. The most common adverse event in the pediatric Phase 3 study was diarrhea which occurred in 4.3% of linaclotide-treated patients versus 1.8% in the placebo group.
FC in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass. FC is a common problem in children of all ages, with a worldwide prevalence ranging between 0.7% and 29.6%. Core symptoms of FC include decreased stool frequency, harder stool consistency, painful passage of stools, and fecal incontinence.
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