BETHESDA, Md., March 13 /PRNewswire/ -- Sucampo Pharmaceuticals, Inc., today announced that it has begun two clinical studies of AMITIZA(R) (lubiprostone) in subjects with either renal or hepatic impairment. AMITIZA was approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of Chronic Idiopathic Constipation in adults. These studies will evaluate the safety and pharmacokinetic profile of a single oral dose (24 mcg) of AMITIZA and will fulfill Sucampo Pharmaceuticals' commitment to the FDA to conduct renal and hepatic impairment post-marketing studies of AMITIZA. These studies are designed to provide additional information about AMITIZA in patients with various degrees of compromised kidney or liver functions. This additional information could be beneficial, in particular, to elderly Chronic Idiopathic Constipation patients who have a greater frequency of renal and hepatic impairment.
"Studies evaluating the safety and efficacy of newly released drugs in special patient populations provide the practicing physician with valuable information relevant to effective patient care," said Philip B. Miner, President and Medical Director of the Oklahoma Foundation of Digestive Research and Clinical Professor of Medicine at the University of Oklahoma. "Patients with compromised kidney and liver function are particularly difficult to manage because of the importance of the liver and kidney in the metabolism of drugs. These new clinical trials will be very useful for making clinical decisions regarding the safe use of AMITIZA for these particular patient groups."
AMITIZA has a novel mechanism of action that works by activating ClC-2 chloride channels to increase fluid secretion in the small intestine, thereby facilitating the passage of stool and improving signs and symptoms associated with Chronic Idiopathic Constipation. AMITIZA is the only prescription medication for Chronic Idiopathic Constipation that has been approved by the FDA for use in adults of all ages, including those 65 years and over, and that has demonstrated effectiveness for use beyond 12 weeks.
About Chronic Idiopathic Constipation
Constipation is one of the most common digestive complaints, affecting more than 42 million people in the United States. Chronic Idiopathic Constipation is defined by the infrequent or difficult passage of the stool for a period of at least three months. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. It is estimated that 12 million people in the United States can be characterized as suffering from Chronic Idiopathic Constipation. The signs and symptoms associated with Chronic Idiopathic Constipation include abdominal discomfort, bloating, straining and hard or lumpy stools.
About AMITIZA(R) (lubiprostone)
AMITIZA is indicated for the treatment of Chronic Idiopathic Constipation in the adult population. AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.
AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.
In clinical trials, the most common adverse event was nausea (31%). Other adverse events (greater than or equal to 5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).
For full prescribing information, visit www.amitiza.com. AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc. Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is an emerging pharmaceutical company based in Bethesda, Md. Sucampo was founded in 1996 by Sachiko Kuno, Ph.D., the company's President and Chair of the Board of Directors, and Ryuji Ueno, M.D., Ph.D., Ph.D., the company's Chief Executive Officer and Chief Scientific Officer. Sucampo focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Dr. Ueno. In January 2006, Sucampo received marketing approval from the FDA for its first product, AMITIZA, for the treatment of Chronic Idiopathic Constipation in adults. In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market AMITIZA in the United States and Canada. Sucampo's specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities. Sucampo has recently completed two pivotal Phase III clinical trials of AMITIZA for the treatment of irritable bowel syndrome with constipation (IBS-C) and expects preliminary results in Q2 2007. Phase III pivotal clinical trials of AMITIZA for the treatment of opioid-induced bowel dysfunction (OBD) are expected to commence in early to mid 2007. To learn more about the company and its products, visit www.sucampo.com.
Any statements in this press release about future expectations, plans, and prospects for Sucampo, including statements containing the words "estimates," "believes," "anticipates," "plans," "expects," "will," and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, many of which are outside of our control. In addition, the forward-looking statements included in this press release represent our views as of March 13, 2007. Subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to March 13, 2007.
Ron Kaiser
Sucampo Pharmaceuticals, Inc.
301-961-3400
Sucampo Pharmaceuticals, Inc.CONTACT: Ron Kaiser, Sucampo Pharmaceuticals, Inc., +1-301-961-3400
