AMITIZA®

In January 2006, Sucampo received marketing approval from the U.S. Food and Drug Administration for its first product, AMITIZAŽ, for the treatment of Chronic Idiopathic Constipation in adults.

AMITIZA® has a novel mechanism of action that works by activating ClC-2 chloride channels to increase fluid secretion in the small intestine, thereby facilitating the passage of stool and improving signs and symptoms associated with Chronic Idiopathic Constipation. AMITIZAŽ is the only prescription medication for Chronic Idiopathic Constipation that has been approved by the FDA for use in adults of all ages, including those 65 years and over, and that has demonstrated effectiveness for use beyond 12 weeks.

In April 2008, the U.S. Food and Drug Administration approved AmitizaŽ (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.

Additional development of AMITIZA® for various gastrointestinal disorders is currently on-going, including a Phase IV study for chronic idiopathic constipation in pediatric patients, a safety study in patients with hepatic impairment and Phase III pivotal trials for opioid-induced bowel dysfunction.

To learn more about AMITIZA and constipation, please visit:
http://www.amitiza.com/
http://www.letstalkconstipation.com/