Sucampo and Takeda announced that the FDA has approved the supplemental New Drug Application (sNDA) for Amitiza (lubiprostone) for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.

Lubiprostone is a specific activator of ClC-2 chloride channels in the intestinal epithelium. By activating apical ClC-2 channels in the intestinal epithelium, lubiprostone bypasses the antisecretory action of opiates.

The FDA approval is based on results from Phase 3 studies of 12-week duration in patients taking opioids (morphine, oxycodone, and fentanyl) chronically for non-cancer pain. In addition, there is data from a long-term, open-label safety study, providing additional support for use in this population.

Amitiza is already indicated for the treatment of irritable bowel syndrome with constipation (IBS–C) in women and for chronic idiopathic constipation in adults.

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