The US Food and Drug Administration has approved Sucampo Pharmaceuticals' new drug application (NDA) for Amitiza (lubiprostone) capsules, an oral treatment of chronic idiopathic constipation in adults.

Amitiza is the first selective chloride channel activator approved for therapeutic use and has been shown to offer effective relief of chronic idiopathic constipation in adults. This condition affects women more often than men and also affects older patients after the age of 65 more frequently, informs the company release.

The approval is primarily based on data from two pivotal, double-blind, placebo controlled studies, which showed that approximately 60 per cent of patients who used Amitiza experienced a spontaneous bowel movement within the first 24 hours. Additionally, Amitiza was shown to decrease abdominal bloating, abdominal discomfort and constipation severity when administered over the 6-12 month treatment period.

"Amitiza provides an onset of action within 24 hours of administration and can provide relief of symptoms of constipation such as stool consistency and straining," said John F. Johanson, clinical associate professor, University of Illinois College of Medicine, and lead investigator on lubiprostone studies since the beginning of phase 2 of development.

Amitiza works by increasing fluid secretion and motility in the intestine, and thereby increasing the passage of the stool and alleviating symptoms associated with chronic idiopathic constipation.

"Amitiza delivers targeted, predictable relief to help people with chronic constipation," said Sachiko Kuno, co-founder, president and chief executive officer of Sucampo.

Amitiza will be jointly marketed by Sucampo Pharmaceuticals Inc., and Takeda Pharmaceuticals America Inc., a wholly owned subsidiary of Takeda Pharmaceuticals North America Inc., and will be available in the United States in spring of 2006.

Constipation is one of the most common digestive complaints, affecting over 33 million adults in the United States. It is the cause of 2.5 million visits to physicians and 92,000 hospitalisations annually.

Sucampo Pharmaceuticals Inc. is a science-driven pharmaceutical company, focusing on gastrointestinal and specialty diseases.