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Clinical Data Show That Lubiprostone Is Efficacious And Well Tolerated In Children And Adolescents With Functional Constipation

BETHESDA, Md., Oct. 8, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo"), today announced clinical data showing that lubiprostone is efficacious and well tolerated in children and adolescents with functional constipation. The results were published in the Journal of Pediatric Gastroenterology & Nutrition .

The primary endpoint for the open-label, multicenter, safety and efficacy study was spontaneous bowel movement (SBM) frequency during week 1 versus baseline. The mean SBM frequency significantly increased from 1.5 SBMs/week at baseline to 3.1 SBMs/week at week 1. In addition, lubiprostone was associated with statistically significant improvements in SBM frequency from baseline for up to three additional weeks.

The study enrolled 127 patients between the ages of 3 and 17 at 22 U.S. general pediatric and pediatric gastroenterology centers who weighed at least 12 kg or more, and who reported having fewer than 3 SBMs per week on average. Patients received four weeks of lubiprostone at doses (12 mcg once daily [QD], 12 mcg twice daily [BID], or 24 mcg [BID]) based on age and weight. Of the 127 patients, 124 were treated and analyzed (12 mcg QD, n = 27; 12 mcg BID, n = 65; 24 mcg BID, n = 32), and 109 completed the study. The mean age of treated patients was 10.2 years, and 52% were male.

Common adverse events (AEs) included nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%), and headache (5.6%). Two patients experienced serious AEs (unrelated abdominal pain; unrelated sickle cell crisis).

"Pediatric functional constipation is a common disorder, however there are currently no available prescription treatment options in this patient population," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. "The results of this study support lubiprostone' s potential to become the first prescription treatment option available for children suffering from constipation. Sucampo plans to initiate a late-stage clinical development program, which will consist of two Phase 3, 12-week, placebo-controlled studies, to evaluate lubiprostone for the treatment of pediatric functional constipation later this year."

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