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FDA approves first U.S. drug for IBS-C

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WASHINGTON Takeda and Sucampo Pharmaceuticals’ Amitiza, indicated for treatment of irritable bowel syndrome with constipation, was approved by the Food and Drug Administration for women over the age of 18, according to published reports.

IBS, an ailment characterized by cramping, abdominal pain, bloating, constipation and diarrhea, affects twice as many women as men, the FDA said. The reason for Amitiza’s approval for women only, however, was based on a lack of proof that the drug was effective for men.

“For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities,” said Julie Beitz of the FDA’s Center for Drug Evaluation and Research. “This drug represents an important step in helping to provide medical relief from their symptoms.”

Amitiza (lubiprostone) is already approved for the treatment of chronic idiopathic constipation, though at a much higher dosage than for treatment of IBS-C.

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