Takeda Pharmaceuticals North America (TPNA) and Sucampo Pharmaceuticals have initiated a phase III clinical development programme for lubiprostone in patients with constipation-predominant irritable bowel syndrome (IBS-C). Enrolment for these trials begins this month.
Lubiprostone is an investigational compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation and associated pain and bloating in adults. The IBS-C clinical development programme will include two phase III trials. Each trial will examine more than 500 patients for 12 weeks to evaluate the safety and efficacy of lubiprostone.
John Johanson, clinical associate professor, University of Illinois College of Medicine, and principal investigator says, "Based on results from our phase II study, we believe lubiprostone may have the potential to treat IBS-C, and thus offer a new option for people living with irritable bowel syndrome."
Lubiprostone is a chloride channel activator, a novel compound with a unique mechanism of action.
IBS is a chronic disorder characterized by the multiple symptoms of abdominal pain and discomfort, bloating, and extreme changes of bowel habits such as constipation and/or diarrhoea. IBS is considered to be one of the most common gastrointestinal disorders.