Lubiprostone Proves to be Efficacious in Study
Clinical Data Show That Lubiprostone is Efficacious and Well Tolerated in Children and Adolescents With Functional Constipation
Results Published in Journal of Pediatric Gastroenterology & Nutrition
BETHESDA, Md., Oct. 8, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo"), today announced clinical data showing that lubiprostone is efficacious and well tolerated in children and adolescents with functional constipation. The results were published in the Journal of Pediatric Gastroenterology & Nutrition.
The primary endpoint for the open-label, multicenter, safety and efficacy study was spontaneous bowel movement (SBM) frequency during week 1 versus baseline. The mean SBM frequency significantly increased from 1.5 SBMs/week at baseline to 3.1 SBMs/week at week 1. In addition, lubiprostone was associated with statistically significant improvements in SBM frequency from baseline for up to three additional weeks.
The study enrolled 127 patients between the ages of 3 and 17 at 22 U.S. general pediatric and pediatric gastroenterology centers who weighed at least 12kg or more, and who reported having fewer than 3 SBMs per week on average. Patients received four weeks of lubiprostone at doses (12 mcg once daily [QD], 12 mcg twice daily [BID], or 24 mcg [BID]) based on age and weight. Of the 127 patients, 124 were treated and analyzed (12 mcg QD, n=27; 12 mcg BID, n=65; 24 mcg BID, n=32), and 109 completed the study. The mean age of treated patients was 10.2 years, and 52% were male.
Common adverse events (AEs) included nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%), and headache (5.6%). Two patients experienced serious AEs (unrelated abdominal pain; unrelated sickle cell crisis).
"Pediatric functional constipation is a common disorder, however there are currently no available prescription treatment options in this patient population," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. "The results of this study support lubiprostone' s potential to become the first prescription treatment option available for children suffering from constipation. Sucampo plans to initiate a late-stage clinical development program, which will consist of two Phase 3, 12-week, placebo-controlled studies, to evaluate lubiprostone for the treatment of pediatric functional constipation later this year."
More information about the study can be found on ClinicalTrials.gov: NCT00452335.
Lubiprostone is available under the brand name AMITIZA® in the U.S. AMITIZA capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults and OIC in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for irritable bowel syndrome with constipation (IBS-C) in women > 18 years old (8 mcg twice daily).
Important Safety Information
AMITIZA (lubiprostone) 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 healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
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 HCP.
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Patients should be instructed to discontinue AMITIZA and inform their HCP if severe diarrhea occurs.
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 HCP. Some patients have discontinued therapy because of dyspnea.
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with 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 (24 mcg twice daily vs. placebo; N=860 vs. N=632) in patients with OIC, the most common adverse reactions (incidence >4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).
In clinical trials of AMITIZA (8 mcg twice daily vs. placebo; N=1011 vs. N=435, respectively) in patients with IBS-C the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.
The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.
Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.
For further information, please visit www.sucampo.com/products for complete Prescribing Information.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global biopharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo's Chairman, Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is also a registered trademark of Sucampo AG.
Sucampo Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's most recent Form 8-K and 10-K, which Sucampo incorporates by reference.
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CONTACT: Silvia Taylor
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Posted: October 2013