BETHESDA, Md., Sept. 4, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") will be presenting data from four separate phase 3 studies evaluating the overall efficacy of AMITIZA (lubiprostone) as a treatment for adults with chronic, non-cancer pain suffering from opioid-induced constipation (OIC). One of the presentations will also include results of AMITIZA's long-term safety and another will highlight novel data indicating that the treatment does not interfere with the analgesic effect of opioids in adult patients. Sucampo will present these data during PAINWeek 2013 in Las Vegas on Thursday, September 5, at 6:15 p.m. PDT.
"Oral lubiprostone has been demonstrated to significantly improve OIC symptoms, and continues to be well tolerated by patients," said Sucampo's Chairman, Chief Executive Officer, and Chief Scientific Officer Ryuji Ueno, M.D., Ph.D., Ph.D. "We are pleased to present these data that build on the body of clinical evidence and real-world experience that support AMITIZA as a treatment for OIC."
AMITIZA is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic constipation. Based on the data to be presented, AMITIZA does not interfere with the analgesic effect of opioids in adult patients.
The following posters will be presented during the Poster Session at PAINWeek 2013 on Thursday, September 5, between 6:15 p.m. – 7:30 p.m. PDT at Level 2, Condesa 4:
- A phase 3, randomized, double-blind, placebo-controlled clinical trial of lubiprostone for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain
- Byron Cryer, MD, Seymour Katz, MD, Taryn R. Joswick, BS, PMP, Gayle R. Dolecek, PD, MPH, Ryuji Ueno, MD, PhD, PhD, Poster 44
- Lubiprostone for Treatment of Opioid-Induced Constipation Does Not Interfere With Opioid Analgesic Effects in Patients With Non-Cancer Pain
- Egilius L. H. Spierings, MD, PhD, Taryn Joswick, BS, PMP, Shadreck Mareya, PhD, Yijun Sun, PhD, Ryuji Ueno, MD, PhD, PhD, Poster 60
- Lubiprostone significantly improves constipation induced by non-methadone opioids in patients with chronic, non-cancer pain: results from a phase 3, randomized, double-blind, placebo-controlled clinical trial
- M. Mazen Jamal, MD, MPH, Shadreck M. Mareya, PhD, Taryn R. Joswick, BS, PMP, Ryuji Ueno, MD, PhD, PhD, Poster 61
- Long-term safety and efficacy of lubiprostone in opioid-induced constipation in patients with chronic, non-cancer pain: results from a phase 3, open-label clinical trial
- Spierings, Egilius L., Joswick, Taryn, Lindner, Elizabeth, Woldegeorgis, Fasil, Ueno, Ryuji, Poster 43
Additional information about the PAINWeek 2013 conference can be found at http://conference.painweek.org/.
About AMITIZA
AMITIZA (lubiprostone) 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.
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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