Sucampo Pharmaceuticals Inc. says that regulators have extended a new review of its constipation drug Amitiza.
Sucampo and its partner, Japanese drugmaker 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.
Release Date: November 30, 2012
Source: The Associated Press