Sucampo Pharmaceuticals, Inc. (SCMP)

[surf1944]

6:49AM Sucampo Pharma announces clinical data showing that lubiprostone is efficacious and well tolerated in children and adolescents with functional constipation (SCMP) 6.38 : Co 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. 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 ncluded 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).