The US Food and Drug Administration (FDA) has approved prucalopride tablets for adults with chronic idiopathic constipation (CIC). CIC affects roughly 35 million adults in the United States. Prucalopride, selective serotonin–4 (5-HT4) receptor agonist, enhances bowel motility by stimulating colonic peristalsis. In October, the FDA's Gastrointestinal Drugs Advisory Committee voted unanimously to approve prucalopride for adults with CIC, as reported by a new website.
The committee considered data from five randomized, double-blind, placebo-controlled phase 3 trials and one phase 4 double-blind, placebo-controlled trial that included a total of 2484 patients with CIC. Four studies evaluated prucalopride 2 mg/day in comparison with placebo. Two evaluated prucalopride 2 mg/day in patients younger than 65 years. For patients aged 65 years and older, prucalopride was administered at an initial…
