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Sucampo Pharmaceuticals, Inc.
SCMP (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
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