Sucampo Pharma Announces Clinical Data On Lubiprostone - Quick Facts

(RTTNews) - Sucampo Pharmaceuticals Inc. (SCMP) 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 or 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 company stated that 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.

The company said it 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.

The company noted that Lubiprostone is available under the brand name AMITIZA in the U.S. AMITIZA capsules are indicated for the treatment of chronic idiopathic constipation or CIC in adults and OIC in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for irritable bowel syndrome with constipation (IBS-C) in women > 18 years old (8 mcg twice daily).