Astellas announces positive constipation trial data for linaclotide

Astellas has announced that its drug linaclotide has demonstrated effectiveness in the treatment of chronic constipation in a new clinical trial.

Conducted in partnership with Ironwood Pharmaceuticals, the phase III study was conducted in Japan and involved 186 adult patients, who were randomised to receive either 500 mcg of linaclotide or placebo for four weeks.

Topline results show that linaclotide-treated patients experienced statistically significant improvements in terms of spontaneous bowel movement frequency after one week, thus meeting the primary efficacy endpoint of the trial.

These results for linaclotide in chronic constipation represent the ninth phase III/IIIb clinical trial in which the drug has met its primary endpoints. It is approved for the treatment of irritable bowel syndrome with constipation or chronic idiopathic constipation in more than 30 countries.

Dr Bernhardt Zeiher, president for development at Astellas, said: "If approved, Astellas expects linaclotide to provide a new therapeutic option for patients suffering from this condition, in addition to IBS-C, for which linaclotide has already obtained marketing approval in Japan."
 
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