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Sucampo And Takeda Initiate Global Pivotal Phase 3 Program Of Lubiprostone In Pediatric Functional Constipation

BETHESDA, Md. and DEERFIELD, Ill., Dec. 17, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") and its development and commercialization partner Takeda Pharmaceuticals ("Takeda") today announced the initiation of a global pivotal Phase 3 clinical program of lubiprostone in pediatric functional constipation. Functional constipation is a very common gastrointestinal complaint in children and is on the rise. An analysis of longitudinal data in the United States showed a nearly 4-fold increase in rates of constipation over the last decade. 1

Takeda Pharmaceuticals U.S.A., Inc. logo

Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. This Phase 3 program was preceded by an open-label trial in 124 patients aged 3 to 17 years, which suggested that lubiprostone warrants further investigation as a potential treatment for children and adolescents with functional constipation.

Estimates of the prevalence rate of functional constipation in the pediatric population worldwide have varied from 4 to 37%. 2 Only 50 to 70% of children with functional constipation demonstrate long-term improvement with the current treatments. 3

"I am very pleased to be participating in this pivotal program which will study lubiprostone for pediatric functional constipation," said Paul Hyman, MD, Investigator and Professor of Pediatrics, Division Head, Gastroenterology, Children's Hospital at New Orleans, Louisiana State University Health Science Center. "There is an unmet need for alternatives to traditional laxative therapy in the pediatric population, and there are currently no prescription products indicated for long-term use in this population. We look forward to conducting this study to determine whether lubiprostone may be a valuable treatment alternative for these pediatric patients."

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