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Prucalopride succinate is a chemically synthesised substance classified as a 5-HT4 receptor agonist. It is known under the trade name Resolor and is available as 1 mg and 2 mg tablets in the United Kingdom.[4] The substance is authorised for the treatment of chronic constipation in women, and in men according to its licensed indication.[2] In the clinical trial data provided, prucalopride appears both as the test substance and as a placebo in one trial each.[1]
Prucalopride succinate is a chemical substance that belongs to a class of medicines called 5-HT4 receptor agonists. It is the active ingredient in Resolor, a medicine approved by the European Commission in October 2009 for the symptomatic treatment of chronic constipation in women when laxatives do not provide adequate relief.[3] In the United Kingdom, prucalopride is listed in the formulary for chronic constipation in line with NICE TA211 for women and its licensed indication in men.[2] The product records from the CTIS registry list the substance as investigational with no marketing authorisation in those records, supplied by Centre Hospitalier Universitaire de Grenoble.[1]
Prucalopride is a 5-HT4 receptor agonist. This means it activates serotonin receptors of the 5-HT4 type, which are found in the digestive tract and also in the brain. In the gut, this activation stimulates bowel movements and helps relieve constipation.[3] In the trial described here, researchers are investigating whether the same mechanism could speed up the therapeutic effect of an SSRI antidepressant, escitalopram, in people with depression.[1]
In the clinical trial, prucalopride is given as a capsule for oral use at a dose of 1 mg.[1] The authorised medicine Resolor is available as 1 mg and 2 mg film-coated tablets taken orally.[4] In earlier studies in chronic constipation, adult subjects under 65 years took 2 mg once daily, while subjects aged 65 and over started at 1 mg once daily.[3]
One Phase 2 clinical trial, registered in the EU Clinical Trials Information System, is investigating prucalopride in depression. The trial is authorised and plans to enrol 70 participants.[1]
The main outcome is the average change in the HDRS-21 depression score between day 0 and day 14. The HDRS-21 is a 21-item rating scale used to assess the severity of depression. The trial compares the group treated with escitalopram plus prucalopride against the group treated with escitalopram plus placebo.[1]
The trial includes patients presenting with a characterised depressive state. The registry record does not provide additional details on inclusion or exclusion criteria.[1]
The supplementary sources provided do not include detailed information on side effects of prucalopride. One source notes that stability concerns exist for prucalopride tablets when repackaged, and advises monitoring for changes in efficacy or adverse effects after repackaging.[4] Earlier studies evaluated safety and tolerability of prucalopride in male subjects with chronic constipation over 12 weeks of treatment.[3]
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