Sucampo Pharmaceuticals is reporting positive results from a Phase III trial with lubiprostone tested in opioid-induced bowel dysfunction (OBD) patients with chronic, noncancer-related pain. “These data will be an important part of our supplemental new drug application (sNDA),” says Ryuji Ueno, M.D., Ph.D., chair, CEO, and CSO of Sucampo. “With these data and those of the previously completed Phase III trials, we now have all the necessary data for submission and are preparing to file the sNDA mid-year with a request for priority review.”
Lubiprostone, a chloride channel activator, is approved as Amitiza for the treatment of chronic constipation (24 mcg twice daily) in adults and for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older.
The Phase III OBD trial was an open-label study that treated 439 subjects over 36 weeks at 116 sites. Treatment with lubiprostone demonstrated consistent improvements over baseline with respect to bowel frequency rates and other OBD-related symptoms at each timepoint measured throughout the study.
The most common adverse events (greater than 5%) were diarrhea, nausea, upper respiratory infection, and back pain. The most common adverse events that were considered treatment-related (greater than 2%) were nausea and diarrhea. Overall, 3.4% and 5.2% of patients withdrew from the trial due to lack of efficacy or adverse events, respectively, over the nine-month treatment period.