BETHESDA, Md., Feb. 6, 2014 (GLOBE NEWSWIRE) -- Sucampo AG ("SAG"), a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo"), headquartered in Zug, Switzerland, announced today that all physicians in Switzerland are now able to prescribe AMITIZA® (lubiprostone) for chronic idiopathic constipation (CIC), as a result of the revision of the reimbursement limitations by the Bundesamt für Gesundheit (BAG), effective February 1, 2014.
In September 2013, SAG requested that the BAG revise several limitations with which AMITIZA was first approved for reimbursement and inclusion in the specialty list (SL), to make it easier to prescribe AMITIZA to patients who have failed previous treatments with at least two laxatives over a nine month period. The SL limitations that were revised are:
- All Swiss physicians, not just gastroenterologists, are now allowed to prescribe AMITIZA;
- The change in the maximum treatment duration of AMITIZA increased from 12 to 52 weeks before a review is needed by a health insurance health care practitioner; and
- The BAG removed from AMITIZA's SL a group limitation pertaining to the number of AMITIZA packs that physicians can prescribe at one time.
CIC has been estimated to occur in about 1 million people in Switzerland.1 A study was conducted in ten European countries, including Switzerland, and 28% of the participants suffering from constipation for at least 6 months were dissatisfied with their current treatment options using laxatives.2 Safety-related and adverse-effect concerns were also among the reasons reported for dissatisfaction in this study.2 As a result, 83% of these patients are interested in seeking alternative methods to relieve their constipation.2 Additionally, patients in this study reported they want relief from all of their symptoms and to feel normal.
AMITIZA is the world's first chloride channel activator that increases intestinal fluid secretion and softens stool, which facilitates the passage of stool and alleviates symptoms associated with CIC.3 AMITIZA has been prescribed globally 8 million times since 2006.
"Chronic idiopathic constipation is very common and difficult to treat, with many patients dissatisfied with their current treatment. Constipation greatly affects the quality of life of those who suffer from it, and it is in their best interests to quickly obtain effective therapy," said Dr. Helene D. Schaufelberger Uhr, specialized physician in gastroenterology (FMH) in Lugano, Switzerland. "Expanding the prescribing physicians to include all physicians makes it possible for these physicians to prescribe a drug that has been demonstrated to be effective and to normalize bowel function without having to wait for a specialist consultation."
"We are pleased with today's announcement that we believe will expand access to AMITIZA in Switzerland," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer and Chief Scientific Officer of Sucampo. "Allowing all physicians to prescribe AMITIZA and increasing the duration of treatment are positive steps to increasing the availability of the product to patients in Switzerland."
In the United States, AMITIZA 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.
Please visit www.sucampo.com/products for complete Prescribing Information and for further information.
About Sucampo Pharmaceuticals, Inc. and Sucampo AG
Sucampo AG, based in Zug, Switzerland, is a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones. Discovered by the company's scientific founder, 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 the United Kingdom, Switzerland and Japan. 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.
- Suares et al. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106:1582-1591.
- S. Müller-Lissner, J. Tack, Y. Feng, F. Schenck & R. Specht Gryp. Levels of satisfaction with current chronic constipation treatment options in Europe – an internet survey. Aliment Pharmacol Ther 2013; 37: 137–145.
- AMITIZA Prescribing Information, 2013.
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Source:Sucampo Pharmaceuticals, Inc.