Health & Fitness
Health and Fitness
Health and Fitness
Thu, December 4, 2008
Wed, December 3, 2008
Tue, December 2, 2008
Sucampo Completes Enrollment in Phase 3 Pivotal Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction
BETHESDA, MD--([ BUSINESS WIRE ])--[ Sucampo Pharmaceuticals ], Inc. (NASDAQ:SCMP) today announced that it has completed enrollment and initial dosing of patients in two pivotal phase 3 trials of lubiprostone for the treatment of Opioid-Induced Bowel Dysfunction (OBD).
"If lubiprostone is successful in Phase 3, we believe that it could represent a breakthrough in the treatment of patients suffering from OBD," said Ryuji Ueno, M.D., Ph.D., Ph.D., Founder, Chairman, and Chief Executive Officer. "We have completed enrollment of both pivotal trials of lubiprostone for opioid-induced bowel dysfunction. We are on track to have top-line data from the 12-week treatment period of the program next summer. If the efficacy results are positive, the follow-on nine-month open-label safety study would report top-line results in late 2009. We anticipate filing a sNDA submission to the FDA during 2010, assuming positive efficacy and safety results."
The OBD Pivotal Assessment of Lubiprostone (OPAL) program is designed to evaluate the effect of lubiprostone as a treatment for chronic pain patients suffering from constipation and associated symptoms as a result of chronic opioid therapy. [ Constipation ] and associated symptoms are a common side effect of the use of narcotic medications, such as morphine, codeine and hydrocodone, which are prescribed for chronic pain management. The OPAL program consists of two double-blind, randomized, placebo-controlled trials, and a follow-on nine-month, open-label, safety extension study. A total of 875 patients diagnosed with OBD were enrolled at 187 sites in the US and Canada. Patients will receive one 24-mcg gel capsule of lubiprostone twice a day (a total of 48 mcg daily) or placebo for 12 weeks. The primary endpoint of the trial is the change from baseline in the frequency of spontaneous bowel movements at week 8.
"Since constipation is often the dose-limiting factor in opioid titration for patients with chronic pain, there is a significant need for new and more effective treatments. Constipation can be persistent, difficult to treat and can generate more pain in a patient already suffering from pain," said Egilius L. H. Spierings, M.D., Ph.D., Associate Clinical Professor of Neurology at Brigham and Women's Hospital, Harvard Medical School, and one of the lead principal investigators in the program. "With effective constipation control, effective pain control with opioids is easier to achieve and the treatment is easier to tolerate."
OBD is characterized by infrequent and incomplete bowel movements, hard stool consistency, straining associated with bowel movements and abdominal bloating. 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. As a local activator of type 2 chloride channels in cells lining the small intestine, lubiprostone increases fluid secretion into the intestinal tract with no effect on opioid-induced analgesia. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements.
According to the American Pain Foundation, over 50 million Americans suffer from chronic pain, and nearly 25 million Americans experience acute pain each year due to injuries or surgery. Opioid pain relievers are widely prescribed for these patients, many of whom also develop OBD. We believe over three million people in the U.S. currently suffer from OBD.
About OBD
Opioid-induced Bowel Dysfunction (OBD) comprises a variety of gastrointestinal conditions inclusive of severe constipation brought on by the use of narcotic medications such as morphine and codeine, which are commonly referred to as opioids. Physicians prescribe opioids for patients with advanced medical illnesses as well as those undergoing surgery. Despite their pain-relieving effectiveness, opioids are known to produce gastrointestinal effects that lead to opioid-induced constipation, including inhibition of large intestine motility, decreased gastric emptying and hard stools. Currently, there are no FDA-approved products that are specifically indicated for treatment of OBD. Current treatment options for OBD include the use of stool softeners, enemas, suppositories and peristaltic stimulants such as senna, which stimulate muscle contractions in the bowel. The effectiveness of these products for OBD is limited due to the severity of the constipation caused by opioids. In additions, physicians often cannot prescribe peristaltic stimulants for the duration of narcotic treatment because of the potential for dependence upon these stimulants. As a result, patients frequently must discontinue opioid therapy and endure pain in order to obtain relief from opioid-induced bowel dysfunction.
Lubiprostone, under the trade name [ AMITIZA ]®, is marketed in the United States by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America. Sucampo Pharmaceuticals holds the development and marketing rights to lubiprostone in all other markets.
About Sucampo Pharmaceuticals
Sucampo Pharmaceuticals, Inc., a biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development.
Sucampo Pharmaceuticals is marketing AMITIZA (lubiprostone) 24 mcg in the U.S. for Chronic Idiopathic Constipation in adults and AMITIZA 8 mcg in the U.S. to treat Irritable Bowel Syndrome with Constipation in adult women. Sucampo is also developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., headquartered in Oxford, UK, with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its products, visit [ www.sucampo.com ].
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation
AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ≥18 years of age and older.
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, 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 distention (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, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Please see complete Prescribing Information at [ www.amitiza.com ].
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "should," "would," "could," "will," "may" or other similar expressions. Forward-looking statements include statements about potential trial results, the potential utility of AMITIZA to treat particular indications and expected data availability and regulatory filing dates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those described in Sucampo Pharmaceuticals' filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2007 and other periodic reports filed with the SEC. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals' views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.
