BETHESDA, Md., Oct. 10, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") today announced the presentation of results from a Phase 3, open-label safety and efficacy study of lubiprostone in patients with pediatric functional constipation. These results demonstrate that lubiprostone increased spontaneous bowel movement (SBM) frequency and was well-tolerated in subgroups of children and adolescents with functional constipation. These results will be presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting in Chicago, Illinois on October 11, 2013. Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases intraluminal fluid volume to initiate colonic transit and improve bowel function independent of motility, thereby alleviating symptoms associated with chronic constipation. The completed open-label, multicenter study evaluated both safety and efficacy in a total of 124 children and adolescents (ranging from 3 years through 17 years of age) with functional constipation who were dosed with lubiprostone 12 mcg once daily (QD), 12 mcg twice daily (BID), or 24 mcg BID. "Pediatric functional constipation accounts for 3-5% of pediatric outpatient visits 1 and there is a definite need for new treatment options," said Paul Hyman, MD, lead author, Professor of Pediatrics at Louisiana State University and Chief, Gastroenterology at Children's Hospital. "The positive response reported by children and adolescents in this study shows that lubiprostone may represent a promising option for treating the broad range of patients who suffer from pediatric constipation." In the fourth quarter of this year, Sucampo plans to initiate a series of global, multicenter Phase 3 studies to evaluate the efficacy, safety, and pharmacokinetics of lubiprostone in patients aged ≥ 6 months through 17 years of age with pediatric functional constipation. This program will consist of two randomized, placebo-controlled, double-blinded studies and two long-term safety extension studies.
The following poster will be presented by Dr. Hyman during the Poster Session at NASPGHAN on Friday, October 11, 2013, between 12:15PM to 2:15PM CT:
- Efficacy of Lubiprostone for Treating Functional Constipation in Children and Adolescents in an Open-Label Multicenter Study (Paul Hyman, MD, Taryn Joswick, BS, PMP, Ryuji Ueno, MD, PhD, PhD) Poster 287
- 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.
Sucampo Forward-Looking StatementThis 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. Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals). Twitter LinkedIn Sources:
1. Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology 2006 Apr;130(5):1527–37.
2. Baker SS, Liptak GS, Colletti RB, Croffie JM, Di Lorenzo C, Ector W, Nurko S. Constipation in infants and children: evaluation and treatment. A medical position statement of the North American Society for Pediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 1999 Nov;29(5):612–26.
3. Biggs WS, Dery WH. Evaluation and treatment of constipation in infants and children. Am Fam Physician 2006 Feb;73(3):469–77.
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