Forest Laboratories to announce linaclotide data

Forest Laboratories and Ironwood Pharmaceuticals have announced plans to present results from a phase IIb study assessing the safety and efficacy of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C),

The companies will show this data at the plenary session of the annual scientific meeting of the American College of Gastroenterology in Orlando, Florida on October 7th 2008.

Forest said analysis of these results show the trial met its primary endpoint of a significant change from baseline against placebo towards complete spontaneous bowel movement frequency.

Following this announcement, the firms added they have started a comprehensive phase III clinical programme to assess the efficacy and safety of the compound in patients with irritable bowel syndrome with constipation or chronic constipation.

“In phase IIb studies in patients with irritable bowel syndrome with constipation, linaclotide reduced abdominal pain and relieved constipation-the hallmarks of the condition-throughout the 12-week treatment period,” Forest said.

It added that the most common adverse event in the trial was diarrhoea, but with no associated electrolyte abnormalities or dehydration and discontinuations as a result of this side effect being infrequent.

In September 2007, Forest signed an agreement with Ironwood Pharmaceuticals – then known as Microbia – to co-develop and market linaclotide.