On December 18, 2018, the US Food and Drug Administration approved prucalopride, a selective serotonin–4 (5-HT4) receptor agonist, for the treatment of chronic idiopathic constipation (CIC) in adults. To be marketed under the brand name Motegrity by Shire Pharmaceuticals, prucalopride enhances bowel motility by stimulating colonic peristalsis.
The FDA considered the results of multiple randomized, double-blind, placebo-controlled phase 3 and 4 trials in their decision to approve prucalopride. The integrated efficacy analysis from those trials found significantly higher proportion of patients taking prucalopride experienced, on average, at least three complete spontaneous bowel movements per week during the treatment period than those who were given placebo (27.8% vs 13.2%; odds ratio, 2.68; 95% confidence interval, 2.16 - 3.33; P < .001). A greater proportion of patients taking prucalopride also experienced clinically meaningful improvement in bowel function, a significant reduction in time to first complete spontaneous bowel movement, and a significant reduction in the use of rescue medication, than those given placebo.
In clinical trials, the most common adverse reactions with prucalopride were headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue, but the rate of discontinuation due to adverse events was low (5% with prucalopride 2 mg once daily versus 3% with placebo). However, in clinical trials, suicides, suicide attempts, and suicidal ideation were reported. A causal association between treatment with prucalopride and an increased risk for suicidal ideation and behavior has not been established, but prescribers are advised to monitor all patients treated with prucalopride for persistent worsening of depression or the emergence of suicidal ideation.
For press release from Shire Pharmaceuticals about the approval, click here.
For additional reporting from Medscape, click here.
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