24 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorization of the first medicine specifically for the symptomatic treatment of irritable bowel syndrome (IBS) in the European Union (EU).
The agency is recommending that Constella (linaclotide) be authorised for adults with moderate to severe IBS with constipation (IBS-C), a common subtype of the disease. Linaclotide is a new, synthetic 14-amino-acid peptide, which 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.
Despite affecting up to 20 percent of the Western population, no medicines have been authorized in the EU specifically for the treatment of IBS. Treatments are currently limited to lifestyle modifications such as reducing stress or altering diet, psychological interventions and general symptomatic treatments such as laxatives, antidiarrhoeals and antispasmodics, or unapproved medicines.
The committee based its recommendation on the results of two main clinical studies showing superiority of linaclotide over placebo in terms of improving symptoms after 12 weeks. These effects were sustained for at least six months. However, it 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.