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FDA approves irritable bowel syndrome treatment


 

The Food and Drug Administration has approved an additional indication for plecanatide (Trulance) as a 3-mg, once-daily treatment for irritable bowel syndrome with constipation (IBS-C).

Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).

Plecanatide was approved on the findings of two randomized, double-blind, 12-week, placebo-controlled clinical trials. More than 2,100 adult patients across both trials received either a 3-mg or 6-mg once-daily tablet of plecanatide, or a placebo. The primary endpoints of both studies were greater than 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) for at least half of the 12 treatment weeks.

Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).

Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.

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