Shire’s prucalopride is being assessed by regulators in the US as a treatment for chronic idiopathic constipation (CIC).
The drug is a selective serotonin type 4 (5‑HT4) receptor agonist that stimulates colonic peristalsis, thus increasing bowel motility.
The firm is seeking approval to market prucalopride (SHP555) as a once-daily treatment option for the condition, which is thought to affect around 35 million people in the country.
“Chronic idiopathic constipation is a commonly-occurring condition that affects nearly one in eight people in the United States,” said William Chey, Professor of Gastroenterology & Nutrition Sciences, and director of the GI Nutrition & Behavioral Wellness Program at the University of Michigan Health System, Ann Arbor.
“Many patients use over-the-counter and prescription medicines, including laxatives, but continue to have constipation symptoms.”
In clinical trials, significantly more patients treated with prucalopride versus placebo - 27.8 percent versus 13.2 percent - achieved an average of three or more spontaneous, complete bowel movements per week over the 12-week treatment period.
The most common treatment-emergent adverse events in the prucalopride group were gastrointestinal disorders (nausea, diarrhea, and abdominal pain) and headache.
Prucalopride is already approved and available in the EU where it is marketed under the brand name Resolor, indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.