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BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.
Sucampo and Takeda announced the approval of Amitiza (lubiprostone) for opioid-induced constipation, or OIC, a condition that affects between 40% and 80% of patients taking opioid for pain not related to cancer, and some patients stop taking opioids and attempt to endure the pain rather than living with constipation. The companies said the drug's effectiveness in treating OIC in patients taking certain types of opioids like methadone has not been established.
"This approval from the FDA, which received priority review status, provides the first and only oral treatment option for opioid-induced constipation in adult patients with chronic, non-cancer pain," Sucampo chairman, CEO and chief scientific officer Ryuji Ueno said.