Sucampo and Takeda receives approval for supplemental application for AMITIZA

Sucampo Pharmaceuticals and Takeda Pharmaceuticals U.S.A. announced that the FDA has approved Sucampo's supplemental new drug application 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. This is the third indication for AMITIZA, which is also approved in the U.S. for the treatment of chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women. There are more than 200M prescriptions for opioid use in the U.S. annually, and a substantial number of these prescriptions are for non-cancer chronic pain.

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