Sucampo submits new drug application for lubiprostone


An investigational compound for the treatment of chronic idiopathic constipation

BETHESDA, MD April 1, 2005 Sucampo Pharmaceuticals, Inc., a leader in functional fatty acid research and development, today announced that it has submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) on March 31, 2005 to market lubiprostone, a novel compound with a unique mechanism of action, for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults.

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.

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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