AbbVie (ABBV) and Ironwood Pharmaceuticals (IRWD) received US Food and Drug Administration approval for Linzess (linaclotide) to treat children aged seven years and older with irritable bowel syndrome with constipation.

The approval, the first therapy cleared for pediatric patients with the condition, was based on data from adult studies and a 12-week randomized trial in patients aged seven to 17, which showed reductions in abdominal pain and increases in spontaneous bowel movements consistent with adult results, the FDA said Tuesday.

The recommended dose is 145 micrograms once daily. The most common side effect reported was diarrhea, and the treatment is not recommended for patients under two years due to the risk of severe dehydration, according to the agency.

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