Sucampo Presentats Results on Lubiprostone in Pediatric Functional Constipation at NASPGHAN 2013
Sucampo Pharmaceuticals (NASDAQ: SCMP) announced Thursday 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 visits1 and there is a definite need for new treatment options," said Paul Hyman, MD, lead author, Professor of Pediatrics