BioSpace has reported the results of a Phase III study evaluating the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C).

The multicentre study (LIN-MD-31) randomised 803 patients with IBS-C to double-blind treatment with linaclotide (266mcg OD) or placebo for 12 weeks.  The main findings reported were as follows:

• A greater proportion of linaclotide-treated patients compared to placebo-treated patients (19.5% vs. 6.3%, p<0.0001) had, in the same week, at least three complete spontaneous bowel movements (CSBMs) and an increase of one or more CSBMs.

• A greater proportion of linaclotide-treated patients compared to placebo-treated patients (34.3% vs. 27.1%, p=0.0262) had a ≥30% reduction in abdominal pain.

• A greater proportion of linaclotide-treated patients compared to placebo-treated patients (12.1% vs. 5.1 percent, p=0.0004) had, in the same week, a ≥30% reduction in abdominal pain, at least three CSBMs, and an increase of one or more CSBMs.

• A greater proportion of linaclotide-treated patients compared to placebo-treated patients (33.6% vs. 21%, p<0.0001) had, in the same week, a ≥30% reduction in abdominal pain and an increase of one or more CSBMs.

A second Phase III trial of linaclotide in IBS-C is ongoing with results expected in the fourth quarter of 2010.  A New Drug Application is expected to be filed in the US in mid-2011; the trials were designed to also support regulatory submission in Europe.

Please see the press release at the link below for further details.