First new drug for IBS

by Gary Finnegan – Emerging uses of EMA Approved Drugs –

The EMA has given the green light for the first medicine specifically for irritable bowel syndrome (IBS) in the EU.

Constella (linaclotide) will be authorised for adults with moderate to severe IBS with constipation (IBS-C), a common subtype of the disease. The drug, a new synthetic 14-amino-acid peptide works by increasing the secretion of fluid in the intestine and accelerating the movement of material through the gut. It is taken by mouth once a day at least 30 minutes before a meal.

Up to 20% of Western populations are affected by IBS, according to the EMA, but not medicines have been authorised specifically for its treatment until now. People affected by the condition currently rely on changes to lifestyle such as reducing stress, altering diet or using general symptomatic treatments such as laxatives, anti-diarrhoeals and antispasmodics, or unapproved medicines.

The Committee for Medicinal Products for Human Use (CHMP) based its decision on the results of two clinical studies showing linaclotide to be superior to placebo in improving symptoms after 12 weeks. These effects were sustained for at least six months.

However, the expert committee noted that around half of the patients in the main studies did not respond to linaclotide sufficiently, leading to the recommendation that prescribers should assess patients regularly and reconsider treatment if there is no improvement in symptoms after four weeks.

The most common side effect in clinical trials was diarrhoea, which was reported in a fifth of the patients taking the medicine. The Agency is recommending that patients with severe or prolonged diarrhoea should be monitored closely when taking linaclotide and that it should be used with caution in patients prone to water or electrolyte-balance disturbances.

Since diarrhoea appeared to be more common in the elderly and only 5% of the study subjects were over 65 years of age, the Agency has also requested that the marketing-authorisation holder carry out a post-authorisation safety study that specifically includes elderly patients.