Sucampo Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones, and its development and commercialization partner Takeda Pharmaceuticals (Takeda) have initiated a global pivotal phase 3 clinical programme of lubiprostone in paediatric functional constipation. Functional constipation is a very common gastrointestinal complaint in children and is on the rise. An analysis of longitudinal data in the United States showed a nearly 4-fold increase in rates of constipation over the last decade.

Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. This phase 3 programme was preceded by an open-label trial in 124 patients aged 3 to 17 years, which suggested that lubiprostone warrants further investigation as a potential treatment for children and adolescents with functional constipation.

Estimates of the prevalence rate of functional constipation in the paediatric population worldwide have varied from 4 to 37%. Only 50 to 70% of children with functional constipation demonstrate long-term improvement with the current treatments.

"I am very pleased to be participating in this pivotal programme which will study lubiprostone for paediatric functional constipation," said Paul Hyman, MD, Investigator and Professor of Paediatrics, Division Head, Gastroenterology, Children's Hospital at New Orleans, Louisiana State University Health Science Center. "There is an unmet need for alternatives to traditional laxative therapy in the paediatric population, and there are currently no prescription products indicated for long-term use in this population. We look forward to conducting this study to determine whether lubiprostone may be a valuable treatment alternative for these paediatric patients."

This phase 3 programme consists of two well-controlled pivotal studies with similar design - one testing lubiprostone capsules in patients 6 to 17 years of age and another testing lubiprostone liquid formulation in patients aged 6 months to under 6 years. Sucampo also plans to evaluate the long-term safety of lubiprostone in these populations through two open-label extension studies.

The first phase 3 trial in the programme, which has just been initiated, is a randomized, placebo-controlled, double-blind study of the efficacy, safety and pharmacokinetics of lubiprostone in paediatric subjects between the ages of 6 to 17. The trial is expected to enroll more than 500 patients with paediatric functional constipation at up to 100 sites across the United States, Canada, and Europe. Subjects will be treated for 12 weeks with weight-based dosages of 12 mcg or 24 mcg twice daily (BID). The primary endpoint for this trial is overall spontaneous bowel movement (SBM) response. An SBM is a bowel movement that occurs without the use of another constipation treatment such as a laxative, enema, or suppository, during the 24 hours prior to occurrence.

Sucampo plans to file a supplemental new drug application with the US Food and Drug Administration following program completion, which is anticipated by early 2016.

The symptoms of paediatric functional constipation include infrequent bowel movements (BMs), hard stools, large diameter stools and painful passage of stools. Rome III diagnostic criteria for childhood functional constipation dictate that such symptoms occur at least once per week for at least 2 months prior to diagnosis. Children may also experience fecal retention due to withholding.1 There is a tendency to avoid defecation and withhold BMs as a result of pain experienced from the passage of large stools. This withholding of BMs can result in episodes of fecal incontinence. Ninety per cent of paediatric constipation is functional constipation and it occurs in all age groups.

Amitiza (lubiprostone) capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults and opioid induced constipation (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).

Based in Deerfield, Ill., Takeda Pharmaceuticals USA, Inc. and Takeda Development Center Americas, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.  development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.takeda.us.