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.
For more information call (888) 9-AMITIZA or visit www.amitiza.com.