BETHESDA, Md., June 12, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today issued the following statement regarding the Anesthetic and Analgesic Drug Products Advisory Committee (Advisory Committee) meeting's vote:
"As a chloride channel activator, AMITIZA (lubiprostone) has a different mechanism of action than the peripherally acting mu-opioid receptor antagonists (PAMORAS) and is approved by the U.S. Food and Drug Administration (FDA) to treat opioid induced constipation (OIC). AMITIZA has been prescribed over eight million times over more than eight years and has a well-tolerated safety profile, with no cardiovascular precautions or warnings. FDA did not require Sucampo to reevaluate our clinical data for cardiovascular risks, as they did for the PAMORAS, and AMITIZA was therefore not a participant in this week's Advisory Committee," said Peter Greenleaf, Chief Executive Officer of Sucampo. "We believe the outcome of today's Advisory Committee further demonstrates the FDA's awareness that safety, specifically the potential cardiovascular safety associated with the PAMORAS class of compounds, is paramount in assessing alternative therapies for OIC, which is a severe condition that affects 40-80 percent of the estimated 250 million patients who receive prescriptions for opioids each year for non-cancer pain. OIC is still widely under-identified and under-managed, and we believe that potential new entrants to the market can help increase overall awareness of the condition. We remain committed to maximizing AMITIZA's potential and to bringing it to physicians and patients worldwide for the treatment of OIC."
About AMITIZA (lubiprostone)
AMITIZA (lubiprostone) is a member of a class of compounds called prostones that directly activates ClC-2 chloride channels located in the apical membrane of the human intestinal epithelial cells. This activation causes an increase in chloride ions (Cl-) and intestinal fluid secretion into the lumen, thereby promoting the motility of the gastrointestinal (GI) tract contents. AMITIZA is 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.
Please see the Full Prescribing Information here. For further information on AMITIZA, please visit www.sucampo.com/products.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators known as prostones. Prostones are naturally occurring fatty acid metabolites with unique physiological activities. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of prostone-based product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the United Kingdom. For more information, please visit www.sucampo.com.
The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark of Sucampo AG.
AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.
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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 10-Q and 10-K, which Sucampo incorporates by reference.