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

Sucampo announced positive data from a Phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD).

The Phase 3 trial evaluated lubiprostone for OBD in patients with chronic, non-cancer pain, excluding those taking methadone. As previously announced, in this study lubiprostone met its primary endpoint and was found to be safe and well-tolerated.

Results from this trial not previously disclosed include:

  1. The proportion of patients with a first spontaneous bowel movement (SBM), at 4, 8, 12, 24 and 48 hours post-dose was found to be statistically significant over placebo (P=0.002, P=0.017, P=0.021, P=0.016 and P=0.022, respectively) with the median time to first SBM being 24.25 hours for those on lubiprostone versus 38.5 hours on placebo (P=0.019).
  2. Greater proportions of lubiprostone subjects experienced improvement in their OBD symptoms over the 12 week period than did placebo subjects, including: straining associated with SBMs (P=0.002), stool consistency of SBMs (P<0.001), constipation severity (P=0.007), abdominal bloating (P=0.208, not statistically significant) and abdominal discomfort (P=0.048).
  3. Weekly changes from baseline in SBM frequency (lubiprostone vs. placebo) were significantly different at 8 of the 12 treatment weeks for lubiprostone vs. placebo, with overall statistical significance achieved (P=0.005).

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.

For more information visit www.sucampo.com.