Amitiza lubiprostone: Phase III data

A double-blind, international Phase III trial in 439 patients showed that twice-daily 24 ug lubiprostone met the primary endpoint of a significantly greater overall SBM response rate vs. placebo at week 12 (26.9% vs. 18.6%, p=0.035). No drug-related serious adverse events were reported, while diarrhea, nausea, and abdominal pain were reported as the most common adverse events. The trial enrolled patients with chronic, non-cancer pain who were treated with any opioid other than methadone for >=30 days prior to screening. Patients continued their opioid therapy throughout the study. Sucampo and Takeda plan to submit an sNDA for the product to treat OBD this half. ...