Positive Top-Line Results from Phase 3 Long-term, Open-label Safety and Efficacy Trial of Lubiprostone in Opioid-Induced Bowel Dysfunction Patients

Positive Top-Line Results from Phase 3 Long-term, Open-label Safety and Efficacy Trial of Lubiprostone in Opioid-Induced Bowel Dysfunction Patients

BETHESDA, Md., Apr 05, 2012 (BUSINESS WIRE) -- Sucampo Pharmaceuticals, Inc. SCMP +4.56% today announced positive top-line results from an open-label phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.

In this open-label study (439 subjects treated) of 36 weeks' duration there were no reported serious adverse events that were considered drug-related. The most common adverse events (greater than 5%) that arose during the trial were diarrhea (9.6%), nausea (8.9%), upper respiratory infection (6.4%) and back pain (5.2%). The most common adverse events that were considered treatment-related (greater than 2%) were nausea (5.0%) and diarrhea (4.6%). Adverse events were categorized in the study as mild, moderate or severe. Severe events of nausea and diarrhea each occurred in 0.5% of patients. Overall, only 3.4% and 5.2% of patients withdrew from the trial due to lack of efficacy or adverse events, respectively, over the 9-month treatment period. Additionally, treatment with lubiprostone demonstrated consistent improvements over baseline with respect to bowel frequency rates and other OBD-related symptoms at each timepoint measured throughout the study.

"We are highly pleased with the long term safety profile and efficacy observed in this phase 3 trial of lubiprostone in OBD," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chair, CEO and CSO of Sucampo. "These data will be an important part of our supplemental new drug application (sNDA). With these data and those of the previously completed phase 3 trials, we now have all the necessary data for submission and are preparing to file the sNDA mid-year with a request for priority review."

Detailed results from this open-label phase 3 trial will be submitted for presentation at an appropriate medical meeting and for publication in an appropriate peer-reviewed journal.

About the Phase 3 Trial

This Phase 3 trial was a multicenter, open-label extension study designed to evaluate the long-term safety and efficacy of oral lubiprostone given up to 24-mcg twice daily as needed for 36 weeks in OBD patients with non-cancer-related pain. All patients in the study had completed one of two preceding (OBD-0631 or OBD-0632) phase 3 well-controlled efficacy trials of lubiprostone in OBD patients with chronic, non-cancer-related pain. In those randomized, double-blinded trials, patients received placebo or oral lubiprostone 24-mcg twice daily for 12 weeks. Baseline assessments during these double-blind trials were also considered as baseline efficacy assessments for the open-label trial. The long-term safety trial treated a total of 439 patients at 116 sites. Patients continued to be treated consistently with opiate therapy during this open-label study. Together with the preceding trials, patients were treated with lubiprostone for up to 48 weeks.

About Opioid-induced Bowel Dysfunction (OBD)

OBD comprises a variety of gastrointestinal conditions brought on by the use of opioid-based medications such as morphine and codeine. OBD encompasses a range of adverse gastrointestinal effects which includes severe constipation, infrequent and incomplete bowel movements, hard stool consistency, straining associated with bowel movements and abdominal discomfort/pain and bloating. Constipation experienced while taking opioids may be referred to as opioid-induced constipation (OIC). Opioid drugs are used to treat moderate to severe pain. Constipation is one of the most common side effects of opioids, affecting up to 81% of patients, and rarely spontaneously resolves without treatment. Despite their pain-relieving efficacy, opioids are known to produce gastrointestinal effects that lead to OBD, including inhibition of large intestine motility, decreased gastric emptying and hard stools. In addition to a delay in intestinal transit, the reduction in secretion, upregulation of water and absorption of electrolytes in the gut may contribute to the constipating effects of opioids. In a 2011 Cochrane Collaboration Review on the use of laxatives in opioid pain patients (palliative care) they reported there have been no randomized clinical trials on any laxative that evaluated laxation response rates, patient tolerability and acceptability. Some patients discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.

About AMITIZA for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C)

AMITIZA is a chloride channel activator indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older.

Important Safety Information

AMITIZA 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 AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

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 healthcare provider.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.

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 healthcare provider. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation (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 (8 mcg twice daily vs. placebo; N=1011 vs. N=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

For further information please see complete Prescribing Information and visit www.amitiza.com .

About Sucampo Pharmaceuticals

Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on the discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymatic catalysis by 15-PGDH of eicosanoids and docosanoids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo's Chairman and CEO. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding CEO and currently Executive Advisor, International Business Development, and a member of the Board of Directors. For more information, please visit www.sucampo.com .

Sucampo Forward-Looking Statements

This press release contains forward-looking information about the Company's future operating and financial performance, business plans and prospects, in-line products and product candidates, and share-repurchase plans that involves substantial risks and uncertainties. Please refer to the forward looking statement in the earnings release found on our website for additional risk factors affecting our forward looking statements.

SOURCE: Sucampo Pharmaceuticals, Inc.

        Sucampo Pharmaceuticals, Inc.
        Kate de Santis, 1-240-223-3834
        [email protected]