Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced the presentation of pooled data from post-hoc analyses of the two pivotal Phase 3 studies of AMITIZA ® (lubiprostone) for the treatment of irritable bowel syndrome with constipation (IBS-C) at Digestive Disease Week 2012 in San Diego. This analysis of patients presenting with moderate to very severe abdominal pain and fewer than three weekly spontaneous bowel movements (SBMs) at baseline demonstrates that AMITIZA provides a statistically significantly higher proportion of patients with consistent relief from IBS-C symptoms (greater than 30% improvement from baseline in abdominal pain ratings and normalization of bowel frequency for 9 of the 12 treatment weeks) as compared to placebo treatment. “IBS-C can be a debilitating and painful disease with a range of abdominal symptoms including abdominal pain, the severity of which has been associated with altered tight junction protein expression and distribution,” commented Ryuji Ueno, M.D., Ph.D., Ph.D., Chair, CEO and CSO of Sucampo and an author of the poster. “The data from this analysis adds to our understanding of AMITIZA, a chloride channel activator, in its role in the treatment of moderate to very severe IBS-C.” The poster entitled “Patient Response to Lubiprostone for the Treatment of Moderate to Severe Irritable Bowel Syndrome with Constipation (IBS-C),” was authored by Taryn R. Joswick, Fasil Woldegeorgis and Ryuji Ueno, all of Sucampo Pharmaceuticals, Inc. About the Analysis Data from two pivotal Phase 3, placebo-controlled, 12-week studies were pooled and post-hoc analyses were conducted to evaluate improvements in subsets of patients with moderate to very severe IBS-C. Patients with documented IBS-C, as defined per Rome II criteria, were randomized in a 2:1 ratio to receive lubiprostone 8-mcg, or placebo, twice daily (BID), for a 12-week treatment period in either of two pivotal, Phase 3, well-controlled studies. A responder analysis of patients with mean weekly abdominal severity of moderate or worse at baseline and less than 3 SBMs per week demonstrated that a greater proportion of lubiprostone patients (N=199) reported ≥30% improvement form baseline in mean abdominal pain scores, ≥1 SBM per week improvement over baseline and ≥3 SBMs per week compared to placebo (N=119) for 6 of 12 weeks (24.1% vs. 9.2%, p=0.0031) and for 9 of 12 weeks (12.6% vs. 3.4%, p=0.0109). (Note that greater than or equal to 3 SBM’s per week is generally considered to be within the normal range). Lubiprostone was well tolerated throughout the study, with the most common adverse events (greater than 4%) in these patients being nausea (9.3% vs. 5.8%), headache (4.9% vs. 1.7%), and diarrhea (4.4% vs. 1.7%) for lubiprostone vs. placebo, respectively. AMITIZA was well-tolerated in this group of patients as well, with the most common adverse events (greater than 4%) being nausea (9.8% vs. 5.7%), diarrhea (6.7% vs. 4.3%) and upper respiratory infection (4.9% vs. 2.9%) for lubiprostone vs. placebo, respectively.
Patients reporting baseline abdominal pain of severe or very severe and taking lubiprostone (n=183) reported statistically significant reduction in abdominal pain overall on a weekly basis over 12 weeks of treatment (p=0.0002) as compared to placebo (n=94), with 35.1% of patients reporting a 30% or greater reduction in abdominal pain as compared to baseline (p<0.0001 vs. placebo).AMITIZA was approved for the treatment of IBS-C in women 18 yrs of age and older by the Food and Drug Administration in 2008. About AMITIZA for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C) AMITIZA is a chloride channel activator indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older. 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 healthcare 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 healthcare 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 healthcare 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 healthcare provider. Some patients have discontinued therapy because of dyspnea.
In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; N=1113 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=1011 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 complete Prescribing Information and visit www.amitiza.com. About Sucampo Pharmaceuticals Sucampo Pharmaceuticals, Inc., an international pharmaceutical company is focused on the discovery, development and commercialization of proprietary drugs 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 Advisor, International Business Development, and a member of the Board of Directors. For more information, please visit www.sucampo.com. Sucampo Forward-Looking Statements 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 US 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 Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.