Novel mechanism of action of lubiprostone provides effective and predictable relief in chronic idiopathic constipation
By Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.
Apr 25, 2006, 21:01

It was announced today that AMITIZA (lubiprostone), 24-mcg soft-gel capsules, approved by the U.S. Food and Drug Administration (FDA) in January 2006, is now available by prescription in pharmacies across the United States for the treatment of chronic idiopathic constipation in adults. AMITIZA (pronounced ahm-e-TEASE-a) is the first selective chloride channel activator approved for therapeutic use in chronic idiopathic constipation, a condition that affects both men and women and affects patients over the age of 65 more frequently.

"AMITIZA is an important new option for people living with chronic idiopathic constipation who may be unsatisfied with traditional treatment options, including lifestyle and dietary changes, laxatives and stool softeners," said Sachiko Kuno, Ph.D., co-founder, president and chief executive officer of Sucampo. "As a science-driven pharmaceutical company, Sucampo is pleased to work with Takeda Pharmaceuticals North America to make this innovative new therapeutic option available to physicians and patients in the United States."

AMITIZA works by increasing fluid secretion locally in the small intestine by activating the ClC-2 chloride channel, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation. In clinical trials, 60 percent of patients who used AMITIZA experienced a spontaneous bowel movement within the first 24 hours.

AMITIZA improved signs and symptoms related to chronic constipation, including abdominal bloating, discomfort, stool consistency and straining. Additionally, these symptomatic improvements lasted over the six to 12 month treatment period.

"The availability of AMITIZAis exciting news for the millions of Americans who suffer from chronic idiopathic constipation and deal with its daily consequences," said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine. "Unlike many treatments that may fail to control symptoms adequately or lose effectiveness with time, AMITIZA provides fast and predictable relief of chronic idiopathic constipation."

AMITIZA is developed by Sucampo Pharmaceuticals, Inc., and will be jointly marketed in the United States by Sucampo Pharmaceuticals, Inc., and Takeda Pharmaceuticals North America, Inc. The AMITIZA sales force in the United States will comprise representatives from both companies.

"Takeda looks forward to working with Sucampo to successfully launch AMITIZA and help make it a trusted and valuable therapy for the treatment of chronic idiopathic constipation," said Art Rice, general manager, Gastroenterology. "AMITIZA has been shown to deliver targeted and predictable relief to people with chronic idiopathic constipation, and we believe that through its novel mechanism of action, this drug may help fill an important therapeutic gap for many patients."

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