Ironwood's linaclotide meets primary endpoint in Phase III chronic idiopathic constipation trials

USA-based Ironwood Pharmaceuticals (Nasdaq: IRWD) has announced positive top-line results from a Phase III trial of 72mcg linaclotide in adults with chronic idiopathic constipation.

Ironwood plans to submit a supplementary New Drug Application to the US Food and Drug Administration in the first half of 2016. The therapy is currently approved by the FDA as a 145mcg capsule to be taken once a day to treat chronic idiopathic constipation and as a 290mcg capsule to be taken once a day to treat irritable bowel syndrome with constipation.

The 72mcg dose of linaclotide demonstrated a statistically-significant improvement compared to placebo on the Complete Spontaneous Bowel Movements Overall Responder endpoint, which was the primary endpoint for the trial. Both the 72mcg and 145mcg doses were well-tolerated during the trial. The most common adverse event reported in linaclotide patients was diarrhea, which was consistent with previous trials, and the majority of which were mild in severity. The discontinuation rate due to diarrhea was low in the 72mcg dose than the 145mcg dose.