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news.Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America have dosed first patient in the third Phase 3 trial evaluating Lubiprostone as a treatment for opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.
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Sucampo Pharma and Takeda are expecting to recruit around 420 patients in 140 sites in US and Europe.
In the trial, the patients will be randomized to receive either placebo or or Lubiprostone 24mcg gel capsule twice daily throughout the 12- week treatment period.
Sucampo Pharma Research & Development senior vice president Gayle Dolecek said that based on previous data, they believe that Lubiprostone has the potential to be US Food and Drug Administration (FDA) approved as an important new treatment option for patients suffering from OBD.