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Published on 30 April 2008

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FDA backs irritable bowel treatment

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The US Food and Drug Administration has approved a new treatment for women who have irritable bowel syndrome with constipation (IBS-C).

Amitiza (lubiprostone) comes in 8mcg capsules and the ruling approves its use twice-daily in women aged over 18.

As a result of the approval, Sucampo Pharmaceuticals will receive a development milestone payment of $50 million from Takeda, its wholly owned subsidiary, in accordance with a deal agreed on 2004 between Sucampo and Takeda to jointly market Amitiza in the US and Canada.

Amitiza is an established therapy for Chronic Idiopathic Constipation in adults. It received FDA approval in January 2006 and has been available for that indication in the US since April 2006.

Ryuji Ueno, CEO at Sucampo Pharmaceuticals, said: “Currently, Amitiza is the only widely available prescription drug therapy to treat Chronic Idiopathic Constipation in adults.

“The approval of IBS-C as an additional indication for adult women validates our commitment to the continued development of Amitiza… in bringing forth effective drugs to serve unmet medical needs.

“Sucampo Pharmaceuticals and Takeda will begin promotion for this indication at Digestive Disease Week 2008, the largest gathering of gastroenterologists, to raise awareness regarding IBS-C and the ability of Amitiza to treat this condition.”

Copyright © PA Business 2008

US Food and Drug Administration



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