NDA for Lubiprostone to treat irritable bowel syndrome with constipation

Sucampo Pharmaceuticals, Inc., has announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

Lubiprostone, developed by Sucampo Pharmaceuticals, is currently approved for the treatment of Chronic Idiopathic Constipation in adults as AMITIZA (24 mcg) and is marketed by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc., (Takeda) in the U.S. for that indication.

“IBS-C has a significant impact on millions of Americans living with the condition,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' founder, chairman and chief executive officer. “We are excited that the results of our clinical studies have led to the successful filing of a supplemental New Drug Application for a lower strength of lubiprostone [8 mcg, twice daily] for IBS-C. If approved, lubiprostone may offer a new treatment option for people living with this condition.”

Approximately 58 million Americans have irritable bowel syndrome, with IBS-C accounting for approximately one-third of these cases. IBS-C symptoms include abdominal pain and discomfort associated with defecation or a change in bowel habits with features of disordered defecation.

The supplemental application is based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,171 adults, followed by one long-term, open-label safety and efficacy extension trial involving 522 adults diagnosed with IBS-C. In the two Phase III studies, patients received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period. In both trials, patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve an overall response that was statistically significant compared to those receiving placebo (P=0.001). The long-term extension trial demonstrated that the efficacy of lubiprostone, established during the double-blinded period, continued overall improvement during the open-label extension period to the end of the 52-week program.

In the pivotal trials, lubiprostone and placebo groups showed a similar incidence of serious adverse events (1% in both the lubiprostone and placebo groups) and related adverse events (22% in lubiprostone vs. 21% in the placebo group). The most common treatment-related adverse events (greater than or equal to 5% of patients) were nausea (8% vs. 4%, respectively), diarrhea (6% vs. 4%, respectively) and abdominal pain (4% vs. 5%, respectively). The incidence of these adverse reactions was lower in the IBS-C clinical trials.

As a result of the supplemental application, Sucampo Pharmaceuticals will be entitled to receive a development milestone payment under the agreement with Takeda.

IBS-C is a chronic disorder characterized by abdominal discomfort, pain, and changes in bowel habits including symptoms of constipation.

In IBS-C, symptoms are present for at least 12 weeks (these do not need to be consecutive) over a 12-month period. Although people with IBS-C report suffering from many of the symptoms associated with constipation, the presence of abdominal discomfort and pain is what differentiates IBS-C from chronic constipation.

Additionally, the hypersensitivity of the gastrointestinal system of individuals with IBS-C makes them more prone to experience the effects of even mild symptoms of constipation. IBS is approximately 2 to 2.5 times more prevalent in women than men.

About AMITIZA® (lubiprostone) 24 mcg Twice Daily for Chronic Idiopathic Constipation

AMITIZA (24 mcg, twice daily) is indicated for the treatment of Chronic Idiopathic Constipation in adults. AMITIZA should not be used in patients with a known gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated 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. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. 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.

AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea or nausea becomes severe, patients should consult their health professional.

In clinical trials for Chronic Idiopathic Constipation (24 mcg twice daily), the most common adverse reaction was nausea (29%). Other adverse reactions (greater than or equal to 5% of patients) included diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distension (6%) and flatulence (6%).

For full prescribing information, visit http://www.amitiza.com

AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.

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