FDA Accepts NDA for Novel Chronic Idiopathic Constipation Treatment

If approved, prucalopride will be the only readily available 5-HT4 agonist for adult CIC in the U.S.
If approved, prucalopride will be the only readily available 5-HT4 agonist for adult CIC in the U.S.

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for prucalopride (Shire), an investigational treatment for chronic idiopathic constipation (CIC).

Prucalopride, a high affinity, selective serotonin type 4 (5-HT4) receptor agonist, is being evaluated as a potential once-daily treatment for adults with CIC. An integrated analysis of 6 main clinical trials (n=2484) found that significantly more patients treated with prucalopride achieved an average of ≥3 spontaneous, complete bowel movements per week over the 12-week treatment period compared to placebo (27.8% vs. 13.2%; P<0.001). 

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With regard to safety, the most common treatment-related adverse events in the prucalopride group were gastrointestinal disorders and headache; the proportion of patients who experienced cardiovascular (CV) events were comparable between the prucalopride and placebo groups (2.0% vs. 1.8%, respectively). As agents similar to prucalopride have been associated with CV events before, an observational, pharmacoepidemiology safety study to estimate major cardiovascular events in prucalopride- vs. polyethylene glycol-treated patients was also included in the NDA.

The FDA is expected to make a decision on prucalopride around December 21, 2018. If approved, the product would be the only readily available 5-HT4 agonist in the U.S. to treat CIC in adults.

For more information visit Shire.com.