Sucampo Pharmaceuticals Inc. (SCMP) and Takeda Pharmaceuticals U.S.A., Inc. said that the United States Food and Drug Administration or FDA has approved Sucampo's supplemental new drug application or sNDA for AMITIZA as the first and only oral medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain. The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids has not been established.
The company said this is the third indication for AMITIZA, which is also approved in the U.S. for chronic idiopathic constipation treatment in adults and irritable bowel syndrome with constipation in adult women.
AMITIZA is a specific activator of ClC-2 chloride channels in the intestinal epithelium. AMITIZA, via activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates.
This approval is based on results from Phase 3, well-controlled studies of 12 weeks' duration in patients taking opioids chronically for non-cancer pain, and a long-term, open-label safety study, which provides additional support for use in this population. Two of the Phase 3 trials met their overall efficacy endpoint, while a third Phase 3 trial did not.
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