Constella | European Medicines Agency (EMA)

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Overview

This is a summary of the European public assessment report (EPAR) for Constella. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Constella.

Constella is a medicine that contains the active substance linaclotide. It is available as capsules (290 micrograms).

Constella is used to treat the symptoms of moderate to severe irritable-bowel syndrome (IBS) with constipation in adults. IBS is a long-term disorder of the gut characterised by pain or discomfort in the abdomen and bloating together with altered bowel habit.

The medicine can only be obtained with a prescription.

The recommended dose of Constella is one capsule once a day, taken at least 30 minutes before a meal.

The doctor should periodically assess the need of continued treatment. If the patient has not experienced an improvement in symptoms after four weeks of treatment, the benefits and risks of continuing treatment should be reconsidered.

The active substance in Constella, linaclotide, attaches to some receptors in the gut called guanylate cyclase C. By attaching to these receptors, it reduces pain and increases the secretion of fluid into the gut, thereby loosening the stools and increasing bowel movements.

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

Constella was investigated in two main studies involving a total of 1,608 patients with IBS with constipation, where it was compared with placebo (a dummy treatment). The main measures of effectiveness were the number of patients who experienced at least a 30% improvement in their pain and discomfort and the number of patients who were considerably or completely relieved from all IBS symptoms for at least six out of the 12 weeks of treatment. One of the studies also looked at the effects of Constella following 26 weeks of treatment.

Constella was shown to be more effective than placebo at improving the symptoms of IBS. In the first study, 55% of patients who received Constella experienced a 30% or higher improvement in their pain and discomfort for at least six out of the 12 weeks of treatment, compared with 42% of patients who received placebo. In addition, 37% of patients who received Constella were considerably or completely relieved from symptoms for at least six out of the 12 weeks of treatment, compared with 19% of patients who received placebo.

Similar results were obtained in the second study, with 54% of Constella patients experiencing an improvement in their pain and discomfort and 39% of them feeling considerably or completely relieved from symptoms for at least six out of the 12 weeks of treatment, compared with 39% and 17% of patients in the placebo group, respectively.

The results after 26 weeks of treatment showed an improvement in pain (for at least 13 weeks out of the 26 weeks) in 54% of patients taking Constella compared with 36% of patients taking placebo, as well as relief from symptoms for at least 13 weeks in 37% of Constella patients, compared with 17% of patients in the placebo group.

The most common side effect with Constella is diarrhoea, mainly mild to moderate, occurring in between 10 and 20 patients in 100. In rare and more severe cases, diarrhoea may lead to dehydration, hypokalaemia (low blood potassium levels), decrease in blood bicarbonate, dizziness and orthostatic hypotension (low blood pressure on standing up).

Constella must not be used in people who are hypersensitive (allergic) to linaclotide or any of the other ingredients. It must also not be used in patients with a known or suspected blockage in their stomach or gut.

The CHMP noted that Constella has been shown to have clinically relevant, beneficial effects in patients with IBS with constipation in the long term (for up to six months). It has also been shown to have a beneficial impact on the quality of life of patients. However, the Committee also noted that about half of the patients did not adequately benefit from treatment, and therefore recommended that the need for continued treatment should be reconsidered after four weeks. Regarding safety, the CHMP concluded that the side effects with Constella, mainly diarrhoea, are manageable. The CHMP therefore decided that Constella’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Constella on 26 November 2012.

For more information about treatment with Constella, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

English (EN)
(57.79 KB – PDF)

First published: 30/11/2012Last updated: 30/11/2012

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English (EN)
(974.29 KB – PDF)

First published: 24/06/2024

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Product information

English (EN)
(186.21 KB – PDF)

First published: 30/11/2012Last updated: 16/10/2024

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Latest procedure affecting product information:
II/0063

05/09/2024

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(24.08 KB – PDF)

First published: 30/11/2012Last updated: 15/05/2023

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Product details

Name of medicine: Constella
Active substance: linaclotide
International non-proprietary name (INN) or common name: linaclotide
Therapeutic area (MeSH): Irritable Bowel Syndrome
Anatomical therapeutic chemical (ATC) code: A06AX04

Pharmacotherapeutic group

Drugs for constipation

Therapeutic indication

Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.

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