Ironwood Pharma's constipation drug meets goal in late-study

Last Updated: 2015-10-13

By Reuters Staff

(Reuters) - Ironwood Pharmaceuticals Inc said on Tuesday a lower dose of its constipation drug met the main goal of improving bowel movements of patients in a late-stage study.

The drug developer said a 72 micrograms (mcg) dose of the drug, linaclotide, fared better than a placebo when evaluated in adults with chronic idiopathic constipation (CIC).

Specifically, top-line data from the Phase III trial indicate that the 72 mcg dose of linaclotide demonstrated "statistically significant improvement compared to placebo on the 12-week Complete Spontaneous Bowel Movements (CSBM) Overall Responder endpoint, the primary endpoint for the trial," the company said in a news release.

In addition, in a pre-specified sensitivity analysis, the 72 mcg dose of linaclotide demonstrated "statistically significant improvement compared to placebo" on the Durable CSBM Overall Responder endpoint, which is currently being requested by the U.S. Food and Drug Administration (FDA) for Phase III CIC trials, the company said.

Both the 72 mcg and 145 mcg linaclotide doses were generally well-tolerated. Consistent with previous Phase III trials of linaclotide, the most common adverse event reported in linaclotide-treated patients was diarrhea.

Ironwood and partner Allergan plc plan to submit a supplemental new drug application to the FDA in the first half of 2016.

Linaclotide is currently approved by the FDA as a 145 mcg capsule to be taken once per day for the treatment of adults with CIC and as a 290 mcg capsule to be taken once per day for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).