Administered orally, the agent has been shown to work locally in the GI tract by activating specific chloride channels (a protein that carries chloride) on cells lining the small intestine, increasing intestinal fluid secretion. This increased fluid level softens the stool, promotes spontaneous bowel movements, and reduces abdominal discomfort, pain and bloating.
"This NDA submission marks a significant product milestone in Sucampo's history. We believe lubiprostone could provide an important new treatment option for the millions of people who suffer from chronic constipation and its difficult symptoms," said Sachiko Kuno, Ph.D., president and chief executive officer of Sucampo. "Our studies suggest that lubiprostone's unique mechanism of action may offer a more targeted approach to managing the symptoms of constipation."
Once the FDA grants approval, Takeda Pharmaceutical Company's U.S. subsidiary will market lubiprostone in the U.S. Sucampo and Takeda reached an agreement in October 2004 that provided Takeda marketing rights for the U.S. and Canada for the agent in the gastroenterology indications, as well as the option for marketing rights in other territories, including Japan and Europe. R-Tech Ueno, Ltd (Tokyo, Japan), a member of Sucampo Group, will manufacture and supply the drug.
For the NDA application, Sucampo provided results from two Phase III pivotal efficacy studies, results of a randomized withdrawal (RW) study and three long-term safety studies, including two 12-month safety studies. These pivotal studies demonstrated that lubiprostone produced rapid and sustained effects in treating the symptoms of constipation, performing significantly better than placebo in men and women over age 18 for all constipation variables tested. Further, results from the RW study indicated no rebound effect after treatment discontinuation.
"We are pleased with this NDA submission by our partner Sucampo, as it surely will support the realization of our ongoing commitment to providing new and innovative options to physicians and their patients," said Yasuchika Hasegawa, president and chief operating officer at Takeda.
In addition to the NDA indication, Sucampo has completed a Phase II trial that studied lubiprostone for constipation-predominant irritable bowel syndrome (IBS-C). The company expects the agent to enter Phase III trials soon. Lubiprostone also is being evaluated for other GI indications.
About Constipation and Chronic Constipation
Constipation, defined as infrequent and difficult passage of stool, is one of the most common disorders suffered by Americans. It affects between two to 27 percent of the population in Western countries. In the United States, it results in more than 2.5 million visits to physicians and 92,000 hospitalizations annually. Factors contributing to the development of constipation include not enough fiber in the diet, lack of exercise, irritable bowel syndrome, neurological and systemic disorders and problems with the colon and rectum or intestinal function. Other contributing factors include side effects from medication, particularly pain medications, antidepressants, antacids, antispasmodics and blood pressure medications. Other contributing factors include side effects from medication, particularly narcotic analgesics, antidepressants, anticholinergics, antispasmodics and antihistamines. Chronic constipation is a disorder of colonic motility that is present for at least three months and results in infrequent bowel movements and demonstrated difficulty in evacuating stools.
About Irritable Bowel Syndrome (IBS)
IBS is a chronic, recurrent disorder characterized by the multiple symptoms of abdominal pain and discomfort, bloating, and extreme changes of bowel habits such as constipation and/or diarrhea. IBS is considered to be one of the most common gastrointestinal disorders. It is reported that approximately 30 million people in North America meet the diagnostic criteria for IBS. There are currently few choices of treatment available for the multiple symptoms of IBS. According to the American Gastroenterological Association, the cause of IBS is not known, although lifestyle factors or psychological stress may play a role. Patients diagnosed with IBS are commonly classified as having constipation-predominant IBS, diarrhea-predominant IBS or alternating IBS (alternating between constipation and diarrhea). The condition causes a great deal of discomfort and distress for its sufferers. While not life threatening, it can significantly interfere with daily activities and reduce their quality of life.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a pharmaceutical company that concentrates on developing compounds from its proprietary functional fatty acid technology platform, which consists of exclusive rights in the Americas to a portfolio of more than 650 patents. The company, founded in 1996 by Dr. Ryuji Ueno and Dr. Sachiko Kuno in Bethesda, MD, focuses principally on developing novel therapies for gastrointestinal, liver and circulatory indications, and is strategically selecting and developing candidates for other indications. Sucampo's functional fatty acid platform is based on the discoveries of Company Founder, Dr. Ryuji Ueno. To learn more about Sucampo, visit www.sucampo.com.
About Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Il., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes and cholesterol-lowering treatments. Through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.