Medication Monitor

Generic Name (Trade Name—Company)
December 20, 2018


FDA approves first serotonin-4 receptor agonist for adults with CIC

Shire announced FDA approval of prucalopride, a once-daily, oral treatment option for adults with chronic idiopathic constipation.

The drug, a selective serotonin-4 (5-HT4) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility.  

Efficacy of once-daily treatment with prucalopride was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks (studies 1–5) or 24 weeks (study 6).

Of the 2,484 patients, most were female (76%) and Caucasian (76%), with an average age of 47 (+/- 16 y).

Most common adverse reactions are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

The drug is expected to launch in 2019 in the United States, where an estimated 35 million adults are living with CIC.