BETHESDA, Md., March 12, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today announced that Sucampo Pharma Europe, Ltd., its wholly owned subsidiary, has received a notice of refusal to grant a Type II variation for AMITIZA® (lubiprostone) 24 mcg for opioid- induced constipation (OIC) from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (U.K.). In 2012, the MHRA approved AMITIZA for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In 2013, the United States (U.S.) Food and Drug Administration approved AMITIZA as the first and only oral medication for the treatment of OIC in adult patients with chronic, non-cancer pain. Sucampo is reviewing the variation assessment report (VAR) from the MHRA and intends to explore all available options for a path forward.
Sucampo completed in 2013 a Type II variation submission to update the Summary of Product Characteristics (SPC) for AMITIZA in the U.K. to include the additional therapeutic indication of OIC in non-cancer pain. MHRA is of the opinion that insufficient evidence of efficacy for the proposed OIC indication had been presented. The MHRA stated in the VAR that the safety profile of lubiprostone appears consistent with what is currently described in the SPC for the approved indication in CIC.
"While we are disappointed with the MHRA decision, we believe in the potential of AMITIZA to meet the unmet medical needs of OIC patients," said Peter Greenleaf, Sucampo's Chief Executive Officer. "AMITIZA is an important treatment option for patients on three continents, with more than 8 million patients treated in its 8 years on the market. Backed by the approval of AMITIZA for OIC in the United States in 2013, we remain fully committed to making AMITIZA available for additional indications in the U.K. and in other geographic markets around the world. Sucampo intends to work closely with the MHRA to determine our path forward."
While the MHRA application included data from the comprehensive, global, multi-study clinical development program for AMITIZA in OIC, which included approximately 1,300 patients across 3 placebo-controlled Phase 3 trials conducted in 7 countries including the U.K., the MHRA considered only one of the studies to be pivotal.
About Opioid-Induced Constipation (OIC)
OIC is a common adverse effect of chronic opioid use. Binding of opioids to peripheral opioid receptors in the gastrointestinal tract decreases both muscle motility and secretion of electrolytes, such as chloride, and causes subsequent reduction in small intestinal fluid. Together, these processes result in OIC, which is characterized by infrequent and incomplete evacuation of stool, hard stool consistency, and straining associated with bowel movements.
About lubiprostone (AMITIZA)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated in the U.S. for the treatment of CIC (24 mcg twice daily) 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 in the U.S. for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older. In Japan, AMITIZA (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In the U.K., AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In Switzerland, AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC.
Important Safety Information – United States
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 visit www.sucampo.com/products for complete Prescribing Information and for further information.
Important Safety Information – United Kingdom
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 to confirm the absence of such an obstruction prior to initiating lubiprostone treatment.
There are no or limited data from the use of lubiprostone in pregnant women. Patients who become pregnant or are planning a pregnancy should be advised to consider the risks and benefits of continued AMITIZA therapy during pregnancy.
Nausea is the most commonly reported adverse drug reaction observed in pivotal clinical studies of AMITIZA, with 23.6% of patients experiencing at least one treatment related nausea event; however, of those patients, 93% reported only a single event during treatment with AMITIZA. Of all reported nausea events, 93.7% were mild to moderate in severity, and 4.0% discontinued treatment as a result of nausea. Administration of AMITIZA with food has been shown to reduce symptoms of nausea.
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 inform their physician if severe diarrhea occurs.
Dyspnea or chest discomfort/pain (usually described as a sensation of chest tightness and/or difficulty taking in a breath) has been reported shortly after taking AMITIZA, and some patients have discontinued treatment. These symptoms generally resolve within a few hours of dosing, but recurrence has been frequently reported with subsequent doses. If these symptoms occur, the patient should seek medical advice before resuming treatment.
In CIC, the safety of AMITIZA has been investigated in 301 patients in 3 pivotal clinical studies. During the pivotal clinical studies conducted on AMITIZA, a number of ADRs have been reported. The most common ADR reported by patients taking AMITIZA was nausea, with diarrhoea and headache also being commonly reported. Treatment-emergent adverse events led to premature study discontinuation for 8% of patients in the pivotal clinical studies.
Please visit http://www.amitiza.co.uk for complete Prescribing Information and for further information.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones. Discovered by the company's scientific co-founder, Ryuji Ueno, M.D., Ph.D., Ph.D., 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, the United Kingdom and Switzerland. 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 a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to 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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Silvia Taylor Senior Vice President, Investor Relations and Corporate Communications 1-240-223-3718
Sucampo Pharmaceuticals, Inc.
Bethesda, Maryland, UNITED STATES
Silvia Taylor Senior Vice President, Investor Relations and Corporate Communications 1-240-223-3718
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