Sucampo Pharma Says FDA Approved SNDA for AMITIZA

Sucampo Pharmaceuticals, Inc.

(SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Sucampo's supplemental new drug application (sNDA) for AMITIZA^® (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) 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 (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult women (8 mcg twice daily). There are more than 200 million prescriptions for opioid use in the U.S. annually, and a substantial number of these prescriptions are for non-cancer chronic pain. ^ Scientific literature indicates that approximately 40-80% of patients taking opioids chronically for non-cancer pain report constipation.