Almirall and Ironwood Pharmaceuticals have released positive Phase III trial results of linaclotide, a treatment for irritable bowel syndrome (IBS) with constipation.
The randomised, placebo-controlled, double-blind, and multi-centre was designed to evaluate the drug’s safety and efficacy.
More than 800 patients with irritable bowel syndrome and constipation were enrolled, and were given either 266µg linaclotide or a placebo for 12 weeks.
The study met its primary endpoint, by exhibiting a clinically relevant improvement of abdominal pain or abdominal discomfort responder and IBS degree of relief responder over the three-month period.
It also met its secondary endpoint, where the patients had an improvement in stool frequency, stool consistency, straining and bloating.
