Sucampo Pharmaceuticals, Inc. and its development and commercialisation partner Takeda Pharmaceuticals USA, Inc. announced that Sucampo Pharma Americas, LLC (SPA) initiated a pivotal clinical trial of a liquid form of lubiprostone 24 mcg BID in adult subjects with chronic idiopathic constipation (CIC).

Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine. This facilitates the passage of stool and alleviates symptoms associated with CIC.

"We are very pleased to announce the initiation of this trial of a new lubiprostone formulation, as many physicians are interested in additional dosing options for their patients," said Ryuji Ueno, MD, Ph.D., chairman, chief executive officer, and chief scientific officer of Sucampo. "While lubiprostone has been approved and is available in the United States, Japan, the United Kingdom and Switzerland, there is still an unmet need in patients who suffer from CIC but will not take lubiprostone in its current capsule form. If approved, alternative dosing options for this CIC patient population, as well as those suffering from OIC, can play an important role in making lubiprostone treatment available to a wider range of patients who may need it."

This pivotal trial is a randomized, placebo-controlled, double-blinded, multi-center study of the pharmacodynamics, pharmacokinetics, and tolerability of a liquid form of lubiprostone in adult subjects =18 years of age with a confirmed diagnosis of chronic constipation. The trial is expected to enroll 152 patients with CIC at approximately 11 sites in the United States.

Sucampo plans to file an NDA upon review of the results of the trial, which is anticipated to end in 2014. Sucampo also plans to study the liquid formulation of lubiprostone in children as part of its upcoming global, multicentre phase III programme to study lubiprostone in paediatric functional constipation.

Lubiprostone is available under the brand name AMITIZA in the US AMITIZA 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).

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones.

Takeda Pharmaceuticals USA, Inc. and Takeda Global Research & Development Centre, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions.