Amitiza(R) For Treatment Of Chronic Idiopathic Constipation
Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza® (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC).
This is the first European regulatory approval for Sucampo and Amitiza is the first prescription medicine to be approved in Switzerland for the long-term treatment of CIC. Amitiza is already approved by the U.S. Food and Drug Administration (FDA) for the long-term treatment of CIC in adults and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women. Amitiza is the only prescription medicine approved by the FDA for either of these indications.
Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, “This approval gives doctors in Switzerland a safe, effective and long-term treatment option for their patients with chronic idiopathic constipation, a life-altering disorder. This decision further validates Amitiza’s position as a safe and effective therapy for a chronic condition.”
Sucampo is now working on the next steps toward pricing and reimbursement to determine distribution alternatives. Sucampo’s goal is to have Amitiza available for eligible patients in Switzerland.
This decision by Swissmedic marks an important milestone in Sucampo’s global development and commercialization plan of lubiprostone for CIC, IBS-C and other indications.
The marketing authorization of Amitiza in Switzerland was based upon an assessment of safety and efficacy data obtained from a comprehensive clinical development program, including results of two randomized pivotal phase 3 clinical trials in adult CIC patients conducted in the U.S. The pooled data from these trials showed that 60 percent of patients treated with Amitiza experienced a spontaneous bowel movement (SBM) within 24 hours of treatment and 80 percent experienced an SBM within 48 hours of treatment, compared to 35 percent and 63 percent of placebo patients, respectively (p<0.0001). Moreover, Amitiza showed improvement in long-term symptom relief of this disorder, with significant improvements in constipation severity, abdominal bloating and abdominal discomfort for up to 12 months.
About lubiprostone
Amitiza is a local activator of type-2 chloride channels in cells lining the small intestine. Amitiza increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. The type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body.
AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation in Adults and Irritable Bowel Syndrome with Constipation in Adult Women
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 http://www.amitiza.com.
Amitiza® is co-marketed in the U.S. by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.
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