Wednesday, Ironwood Pharmaceuticals, Inc. (IRWD) announced that the U.S. Food and Drug Administration has approved the use of LINZESS, also known as linaclotide, in pediatric patients 2 years of age and older with functional constipation.
With this approval, LINZESS remains the only FDA-approved prescription therapy for pediatric functional constipation, a chronic condition characterized by hard, infrequent bowel movements.
The approval is backed by data from a 12-week Phase 3 randomized, placebo-controlled clinical trial, which demonstrated improvement in spontaneous bowel movement frequency compared with placebo.
Currently, IRWD is trading at $3.98, up 2.18 percent on the Nasdaq.
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