AbbVie submits sNDA for functional constipation treatment in pediatric patients
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AbbVie announced that it has submitted a supplemental new drug application for Linzess for the treatment of functional constipation in patients aged 6 to 17 years, according to a press release.
The submission is supported by data from a multicenter double-blind phase 3 study that investigated the efficacy of Linzess (linaclotide 72 mcg, AbbVie/Ironwood) in treating functional constipation across a total of 330 patients who were randomized in a 1:1 ratio between Linzess or placebo.
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In the study, Linzess reportedly demonstrated an improvement in stool consistency and 12-week spontaneous bowel movement (SBM) frequency rates compared with placebo, achieving greater than two-fold least squares mean change from baseline in SBM/week (2.220) when compared with placebo (1.050) (P < .0001), according to the release.
The most common adverse event among patients in the trial was diarrhea, which occurred in 4.3% of patients treated with Linzess compared with 1.8% of patients treated with placebo.
Linzess is currently indicated for the treatment of adults with chronic idiopathic constipation or irritable bowel syndrome with constipation.
"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, MD, PhD, vice president and head of US medical affairs at AbbVie, said in the release. "This milestone demonstrates our tireless work to advance the standards of care in order to make a difference in patients' lives."
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