BETHESDA, Md., Oct. 10, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") today announced the presentation of results from a Phase 3, open-label safety and efficacy study of lubiprostone in patients with pediatric functional constipation. These results demonstrate that lubiprostone increased spontaneous bowel movement (SBM) frequency and was well-tolerated in subgroups of children and adolescents with functional constipation. These results will be presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting in Chicago, Illinois on October 11, 2013.
Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases intraluminal fluid volume to initiate colonic transit and improve bowel function independent of motility, thereby alleviating symptoms associated with chronic constipation. The completed open-label, multicenter study evaluated both safety and efficacy in a total of 124 children and adolescents (ranging from 3 years through 17 years of age) with functional constipation who were dosed with lubiprostone 12 mcg once daily (QD), 12 mcg twice daily (BID), or 24 mcg BID.
"Pediatric functional constipation accounts for 3-5% of pediatric outpatient visits 1 and there is a definite need for new treatment options," said Paul Hyman, MD, lead author, Professor of Pediatrics at Louisiana State University and Chief, Gastroenterology at Children's Hospital. "The positive response reported by children and adolescents in this study shows that lubiprostone may represent a promising option for treating the broad range of patients who suffer from pediatric constipation."In the fourth quarter of this year, Sucampo plans to initiate a series of global, multicenter Phase 3 studies to evaluate the efficacy, safety, and pharmacokinetics of lubiprostone in patients aged ≥ 6 months through 17 years of age with pediatric functional constipation. This program will consist of two randomized, placebo-controlled, double-blinded studies and two long-term safety extension studies.