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).
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.