Resolor (prucalopride) is a serotonin receptor agonist (5-HT4) indicated for symptomatic treatment of chronic constipation in women who do not achieve adequate relief with laxatives. The dosage is 2 mg once daily. Prucalopride is not classified as a laxative (A06), but belongs to the class of drugs intended for treatment of functional gastrointestinal disorders (A03).
The effect is shown in 3 placebo-controlled clinical studies of 12 weeks duration in patients with chronic constipation, primarily women, with a previous consumption of laxatives. Compared to placebo, significantly more patients experienced an improvement in their bowel habits and quality of life after treatment for 12 weeks.
The most frequently observed adverse effects are headache and gastrointestinal symptoms.
It is IRF’s overall assessment that Resolor (prucalopride) has no place in the treatment of chronic constipation in women. The long-term effect and side effect profile, potential adverse cardiac effects in particular, are not adequately described.
Resolor (prucalopride) was marketed October 1st 2012. It is not subject to reimbursement.