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Sucampo Falls As FDA Extends Amitiza Review

From Associated Press (November 30, 2012)

BETHESDA, Md. -- Sucampo Pharmaceuticals Inc. said Friday that regulators extended a new review of its constipation drug Amitiza.

Sucampo and its partner, Japanese drug maker Takeda, want the Food and Drug Administration to approve Amitiza as a treatment for constipation caused by opioid pain medications used by patients with chronic pain not caused by cancer.

The companies originally expected the agency to make a decision on the application by late January, but the review is being extended because the companies submitted more data in response to an FDA request. Amitiza is approved to treat chronic constipation in adults and irritable bowel syndrome with constipation in adult women. Net sales in the third quarter totaled $71.5 million.

Shares of Sucampo rose 2.8 percent to $5.24 on Friday. The shares dropped 44 cents, or 8.4 percent, to $4.80 in aftermarket trading.

Posted: December 2012