Phase 3 Long-Term Safety Trial Results of Lubiprostone in Patients with Irritable Bowel Syndrome with Constipation was Recently Published in Alimentary Pharmacology and Therapeutics
BETHESDA, Md.--(BUSINESS WIRE)--Mar 6, 2012 - A recently published study in the journal Alimentary Pharmacology and Therapeutics, demonstrated the long-term safety and tolerability profiles of AMITIZA (lubiprostone) in patients with irritable bowel syndrome with constipation (IBS-C). This study, initiated by Takeda Pharmaceuticals U.S.A., Inc. and Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), was designed to determine the effects of AMITIZA in patients with IBS-C for up to 52 weeks.
The primary objective of this open-label, extension study (n=520) was to determine the long-term safety and tolerability profiles of AMITIZA when administered twice-daily for 36 weeks (8 mcg twice-daily) to patients with IBS-C. Results indicated that AMITIZA, when administered to IBS-C patients for up to 13 months, continues to demonstrate an acceptable safety and tolerability profile.
“It is important to note that IBS-C is a chronic, long-term condition. Given that AMITIZA is the only drug approved for IBS-C in adult women, it is important to know that it has an established safety and tolerability profile,” said John F. Johanson, MD, MSc, FACP, FACG, Clinical Associate Professor of Medicine, University of Illinois College of Medicine. “Since many of those suffering may be receiving long-term treatment, it is important to have such encouraging data published on the only drug approved for IBS-C in adult women.”
The most common adverse events in this study was diarrhea and nausea (11% each), urinary tract infection and sinusitis (9% each) and abdominal distension (5.8%). There were 11 serious adverse events reported, none of which were considered treatment related. Seventeen patients discontinued for treatment-related adverse events, with diarrhea and nausea accounting for 1.2% (n=6) and 0.6% (n=3) respectively.
In the Amitiza Phase 3 studies, IBS was defined as abdominal pain or discomfort occurring over at least six months with two or more of the following: 1) relieved with defecation; 2) onset associated with a change in stool frequency; and 3) onset associated with a change in stool form. Patients were sub-typed as having IBS-C if they also experienced two of three of the following: 1) less than three spontaneous bowel movements per week, 2) greater than 25% hard stools, and 3) greater than 25% of spontaneous bowel movements associated with straining.
AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice-daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice-daily) in women > 18 years old.
Important Safety Information
AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating health care provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. 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.
Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their health care provider.
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their health care provider if the diarrhea becomes severe.
Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their health care provider. Some patients have discontinued therapy because of dyspnea.
In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; n=1,113 vs. n=316) in patients with Chronic Idiopathic Constipation (CIC), the most common adverse reactions (incidence > 4%) were nausea (29% vs. 3%), diarrhea (12% vs. <1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distension (6% vs. 2%), and flatulence (6% vs. 2%).
In clinical trials of AMITIZA (8 mcg twice daily vs. placebo; n=1,011 vs. n=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8 vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%). Reduce the dosage in CIC patients with moderate and severe hepatic impairment.
Reduce the dosage in IBS-C patients with severe hepatic impairment.
For further information, please see accompanying complete Prescribing Information and visit www.AMITIZA.com.
About Sucampo Pharmaceuticals
Sucampo Pharmaceuticals, Inc. is an international pharmaceutical company is focused on the discovery, development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Executive Advisor, International Business Development, and a member of the Board of Directors. For more information, please visit www.sucampo.com.
AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.
Sucampo Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” ”may” or other similar expressions. Forward-looking statements include statements about the potential utility of AMITIZA® to treat particular indications and expected data availability dates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those described in Sucampo Pharmaceuticals' filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2010 and other periodic reports filed with the SEC. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals' views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.
Contact: Sucampo Pharmaceuticals, Inc.
Kate de Santis, +1-240-223-3834
Posted: March 2012