Ironwood Pharma Says Phase II Trial Of Linaclotide In OIC Meets Primary Endpoint

(RTTNews) - Ironwood Pharmaceuticals Inc. (IRWD) said that the Phase II clinical trial of linaclotide conducted in adults with opioid-induced constipation or OIC met its primary endpoint.

The OIC clinical trial was conducted jointly by Ironwood and a subsidiary of Allergan plc (AGN), Ironwood's co-development and co-commercialization partner for linaclotide in the U.S.

Linaclotide is currently approved in the U.S. for the treatment of adults with IBS-C or CIC. It is also approved for adults with IBS-C or CIC in a number of other countries. Linaclotide is not currently approved for the treatment of OIC.

Top-line data from the trial indicate that linaclotide-treated patients showed statistically significant improvement for the pre-specified primary endpoint: change from baseline in the 8-week Spontaneous Bowel Movement or SBM frequency rate (SBMs/week), during the treatment period, for both doses tested, 145 mcg and 290 mcg, compared to placebo-treated patients.

Consistent with previous Phase III trials of linaclotide in irritable bowel syndrome with constipation or IBS-C, and chronic idiopathic constipation or CIC, the most common adverse event reported in linaclotide-treated patients was diarrhea, with the majority being characterized as mild in severity.

The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial enrolled 254 adult patients with chronic, non-cancer pain who had been receiving a stable dose of an opioid analgesic and suffered from constipation, defined as fewer than three SBMs per week.

Patients were randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks.