Sucampo and Takeda Initiate Pivotal Trial of Lubiprostone Liquid Formulation in Adults With Chronic Idiopathic Constipation

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BETHESDA, Md. and DEERFIELD, Ill., Oct. 23, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") and its development and commercialization partner Takeda Pharmaceuticals U.S.A., Inc. (Takeda) today announced that Sucampo Pharma Americas, LLC (SPA) initiated a pivotal clinical trial of a liquid form of lubiprostone 24 mcg BID in adult subjects with chronic idiopathic constipation (CIC).





Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine. This facilitates the passage of stool and alleviates symptoms associated with CIC.

"We are very pleased to announce the initiation of this trial of a new lubiprostone formulation, as many physicians are interested in additional dosing options for their patients," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. "While lubiprostone has been approved and is available in the United States, Japan, the United Kingdom and Switzerland, there is still an unmet need in patients who suffer from CIC but will not take lubiprostone in its current capsule form. If approved, alternative dosing options for this CIC patient population, as well as those suffering from OIC, can play an important role in making lubiprostone treatment available to a wider range of patients who may need it."

This pivotal trial is a randomized, placebo-controlled, double-blinded, multi-center study of the pharmacodynamics, pharmacokinetics, and tolerability of a liquid form of lubiprostone in adult subjects ≥18 years of age with a confirmed diagnosis of chronic constipation. The trial is expected to enroll 152 patients with CIC at approximately 11 sites in the United States.

Sucampo plans to file an NDA upon review of the results of the trial, which is anticipated to end in 2014. Sucampo also plans to study the liquid formulation of lubiprostone in children as part of its upcoming global, multicenter Phase 3 program to study lubiprostone in pediatric functional constipation.

About lubiprostone

Lubiprostone is available under the brand name AMITIZA® in the U.S. AMITIZA capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults and opioid induced constipation (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, respectively) 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 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.

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Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.takeda.us.

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CONTACT: Silvia Taylor Senior Vice President, IR, PR, and Corporate Communications 1-240-223-3718 staylor@sucampo.com Takeda Pharmaceuticals U.S.A., Inc. Sandy Rodriguez, 1-224-554-5693 sandy.rodriguez@takeda.com

Source:Sucampo Pharmaceuticals, Inc.