Phase 3 Trial Update of Lubiprostone for Opioid-Induced Bowel Dysfunction (OBD)

Sucampo and Takeda Pharmaceuticals announced that lubiprostone met the primary endpoint in a Phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

This Phase 3 trial was a randomized, placebo-controlled, double-blind trial of the efficacy and safety of lubiprostone in patients with opioid-induced bowel dysfunction. The trial enrolled and treated a total of 439 patients in the U.S. and Europe. Patients were evenly randomized to receive either placebo or lubiprostone 24mcg gel capsule twice daily throughout the 12-week treatment period. Patients were treated for chronic, non-cancer related pain with any opioid other than methadone for at least 30 days prior to screening, and continued opioid therapy throughout the study. Patients were confirmed to have OBD, which is defined as having an average of fewer than three spontaneous bowel movements (SBMs) per week during the three-week screening period and at least one of the following for at least 25% of SBMs during each week of the screening period: hard or very hard stools; sensation of incomplete evacuation; moderate to very severe straining associated with SBMs.

The primary endpoint was the overall SBM response rate. The response rate for lubiprostone-treated patients was 26.9% (n=219) versus 18.6% (n=220) for placebo-treated patients (P=0.035).

Lubiprostone (marketed as Amitiza by Sucampo and Takeda), is a chloride channel activator currently indicated for the treatment of chronic idiopathic constipation (CIC) in adults and for irritable bowel syndrome with constipation (IBS-C) in women ≥18 years of age.

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