Swissmedic Approves AMITIZA(R) (Lubiprostone) for the Treatment of Opioid-Induced Constipation

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| Source: Sucampo Pharmaceuticals, Inc.

BETHESDA, Md. and ZUG, Switzerland, July 7, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has approved AMITIZA® (lubiprostone) 24 mcg for the treatment of opioid-induced constipation (OIC) in adults with chronic, non-cancer pain.

This is the second indication approved in Switzerland for AMITIZA, which is also approved for the treatment of chronic idiopathic constipation (CIC). Opioid-based medicines are widely used in the management of chronic pain, with OIC being a common adverse effect of chronic opioid use. OIC is characterized by infrequent and incomplete evacuation of stool, hard stool consistency, and straining associated with bowel movements. Scientific literature indicates that there are approximately 98,000 patients in Switzerland each year suffering from chronic non-cancer related pain1, of which approximately 62,000 require treatment for OIC2.

"OIC is a problem affecting thousands of chronic non-cancer pain patients each year in Switzerland, and its debilitating effects can lead to these patients discontinuing opioid therapy," said Peter Greenleaf, Chief Executive Officer of Sucampo. "We are pleased by Swissmedic's decision and look forward to providing physicians with an important new option to help treat the unmet needs of their patients."

Sucampo first received Swiss marketing authorization in November 2009 for the use of AMITIZA in the treatment of patients with CIC. Over 8 million prescriptions of AMITIZA have been filled globally since 2006.

About AMITIZA (lubiprostone)

AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated in Switzerland, (24 mcg twice daily) for the treatment of CIC in adults and for the treatment of OIC and associated signs and symptoms such as stool consistency, straining, constipation severity, abdominal discomfort, and abdominal bloating in adults with chronic, non-cancer pain. The efficacy of AMITIZA for the treatment of OIC in patients taking opioids of the diphenylheptane class, such as methadone, has not been established.

Short Prescribing Information for AMITIZA® (lubiprostone) (Switzerland)

Before prescribing AMITIZA please consult the full Prescribing Information (www.swissmedicinfo.ch).

Composition: Soft capsule, 24 µg lubiprostone. Indication: treatment of chronic idiopathic constipation in adults aged 18 and above and treatment of opioid-induced constipation in adults with chronic non-cancer pain. The efficacy of Amitiza in patients taking opioids of the diphenylheptane class (e.g., methadone) has not been established.

Dosage: One 24 µg capsule should be taken twice daily with food. The need for continued therapy must be assessed at regular intervals by stopping treatment.

Contraindication: must not be used for patients with a medical history of known or suspected mechanical gastrointestinal obstructions or with known oversensitivity to the active ingredient or one of the excipients.

Precaution: Patients may experience nausea. If this occurs, concomitant administration of food may reduce symptoms. AMITIZA should not be prescribed to patients that have severe diarrhoea. Patients should be aware of the possible occurrence of diarrhoea during treatment and inform their health care provider if diarrhoea becomes severe. No dosage adjustment is required for patients with mild hepatic impairment. For patients with moderate to severe hepatic impairment (Child-Pugh classification B or C), the initial dosage should be decreased to 24 micrograms (1 capsule once a day with breakfast or supper). If the initial dose is tolerated and an adequate response has not been obtained after an appropriate interval, the dose can be increased to full dosing (one capsule twice daily) with appropriate monitoring of patient response. Patients may experience dyspnea within an hour of first dose. This symptom generally resolves within hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their doctor. Interaction: It is unlikely that lubiprostone will cause interactions with other medications.

Pregnancy and lactation: Amitiza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breast-feeding during use of AMITZA is not recommended.

Side effects: Most common in clinical studies (in over 10% of patients) were nausea, diarrhoea and headaches. Other side effects (in over 1% of patients) were abdominal pain, abdominal distension, flatulence, vomiting, dizziness, peripheral oedema, fatigue, chest discomfort or pain, dyspnea, abdominal discomfort, dyspepsia, and dry mouth. Although dyspnea is not classified as severe, some patients discontinued treatment.

Packaging: Soft capsules in HDPE bottles of 28 and 56 (B) with seal and rayon filler.

State of information: June 2014. Sucampo AG, Zug.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of medicines to meet the major unmet medical needs of patients on a global basis. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of 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 8-K and 10-K, which Sucampo incorporates by reference.

References:

  1. Breivik H, et al. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333
  2. Hess B, et al. Attitude of Swiss physicians towards opioid-induced constipation: a national survey. Eur J Intern Med. 2011; 22(5):527-31
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and
Corporate Communications
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