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IBS drug approved in the US

The US Food and Drug Administration has approved Amitiza for an additional indication to treat irritable bowel syndrome with constipation.

The US Food and Drug Administration (FDA) has approved Amitiza for an additional indication to treat irritable bowel syndrome with constipation (IBS-C).

The drug (lubiprostone), which was developed as part of a joint deal between Sucampo and Takeda Pharmaceuticals North America, can now be prescribed to women over the age of 18 for the treatment of IBS-C.  It is the only drug available for this therapeutic use and its efficacy was established during two major clinical trials that involved mostly female patients, only 8 per cent being male.

Dr Julie Beitz, director of the Office of Drug Evaluation III at the Centre for Drug Evaluation and Research, FDA, said: "For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities. This drug represents an important step in helping to provide medical relief from their symptoms."

In keeping with a joint licensing agreement signed in October 2004, Sucampo will receive a milestone payment of $50m from Takeda in light of the FDA approval for Amitiza. The drug was previously given marketing authorisation in 2006 for the treatment of patients with chronic idiopathic constipation.

Yasuchika Hasegawa, president of Takeda, said: "This additional indication for Amitiza will help Takeda further enhance our position in the US primary care and GI speciality markets."

Sucampo and Takeda said that they plan to promote the drug for its newly approved indication during Digestive Week 2008 in May.

Dr Ryuji Ueno, founder, chairman and chief executive officer of Sucampo, said: "The approval of IBS-C as an additional indication for adult women validates our commitment to the continued development of Amitiza for further indications."

30th April 2008

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