Resolor

Active Substance: prucalopride
Common Name: prucalopride
ATC Code: A06AX05
Marketing Authorisation Holder: Movetis NV
Active Substance: prucalopride
Status: Authorised
Authorisation Date: 2009-10-15
Therapeutic Area: Constipation
Pharmacotherapeutic Group: Other drugs for constipation

Therapeutic Indication

Resolor is indicated for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.

What is Resolor?

Resolor is a medicine that contains the active substance prucalopride. It is available as round tablets (white: 1 mg and pink: 2 mg).

What is Resolor used for?

Resolor is used to treat symptoms of chronic (long-term) constipation in women for whom laxatives (medicines that trigger bowel movements) do not work well enough.

The medicine can only be obtained with a prescription.

How is Resolor used?

The recommended dose of Resolor is 2 mg taken once a day. Women aged over 65 years should start with a 1-mg dose once a day, and this can be increased to 2 mg once a day if needed.

Resolor can be taken with or without food at any time of the day.

How does Resolor work?

The active substance in Resolor, prucalopride, is a ‘5-HT4-receptor agonist’. This means that it works like a substance in the body called 5-hydroxytryptamine (5HT, also known as serotonin) and attaches to the same receptors in the gut called ‘5-HT4 receptors’. When it binds to these receptors, 5HT normally stimulates movement in the gut. In the same way, when prucalopride attaches to and stimulates these receptors, it increases this movement and allows the bowels to empty faster.

How has Resolor been studied?

The effects of Resolor were first tested in experimental models before being studied in humans.

In three main studies involving 1999 patients with chronic constipation, 88% of whom were women, Resolor (2 or 4 mg once a day) was compared with placebo (a dummy treatment). The patients had not responded well enough to previous treatment with laxatives. The main measure of effectiveness was the number of patients who completely emptied their bowels at least three times a week over a 12-week period without the help of laxatives.

What benefit has Resolor shown during the studies?

Resolor was more effective than placebo at treating chronic constipation. Over the 12-week period, 24% (151 out of 640) of patients who received Resolor 2 mg completely emptied their bowels at least three times a week, compared with 11% (73 out of 645) of patients who received placebo. The result from patients who received Resolor at the higher dose of 4 mg was similar to those who took the 2 mg dose.

What is the risk associated with Resolor?

The most common side effects with Resolor (seen in more than 1 patient in 10) are headache, nausea (feeling sick), diarrhoea and abdominal (tummy) pain. For the full list of all side effects reported with Resolor, see the package leaflet.

Resolor should not be used in people who may be hypersensitive (allergic) to prucalopride or any of the other ingredients. It must not be used in patients with kidney problems requiring dialysis (a blood clearance technique). It must also not be used in patients with intestinal perforation or obstruction, severe inflammatory conditions of the intestines such as Crohn’s disease, ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) and toxic megacolon and megarectum (a very serious complications of colitis).

Why has Resolor been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that almost all the patients in the main study were women and that new data is required to understand how the medicine works in men. Based on the available data, the CHMP decided that Resolor’s benefits are greater than its risks for the treatment of the symptoms of chronic constipation in women for whom laxatives fail to provide adequate relief. The Committee recommended that Resolor be given marketing authorisation.

Other information about Resolor

The European Commission granted a marketing authorisation valid throughout the European Union for Resolor to Movetis NV on 15 October 2009.

Source: European Medicines Agency

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