AMITIZA® Approved for IBS With Constipation in Adult Women

BETHESDA, Md., DEERFIELD, Ill. & OSAKA, Japan -- Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited and its subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Sucampo Pharmaceuticals’ supplemental New Drug Application (sNDA) for AMITIZA® (lubiprostone) 8 mcg capsules twice daily to treat irritable bowel syndrome with constipation (IBS-C) in women 18 years of age or older.

AMITIZA, developed by Sucampo Pharmaceuticals, is an established therapy for chronic idiopathic constipation in adults. It received FDA approval in January 2006 and has been available for that indication in the United States since April 2006. The product is co-marketed in the United States by Sucampo Pharmaceuticals and Takeda through Takeda Pharmaceuticals North America, Inc.

The sNDA was based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,154 adults, followed by one long-term, open-labeled extension trial involving 476 adults diagnosed with IBS-C. In the two Phase III studies, patients received AMITIZA 8 mcg or placebo taken twice daily over a 12-week period. In both trials, patients receiving AMITIZA 8 mcg twice daily were nearly twice as likely to achieve an overall response that was statistically significant compared to those receiving placebo. The safety profile of AMITIZA was established during the double-blinded period, and further confirmed by an open-labeled extension period with a total treatment period of up to 52 weeks.

In the pivotal three-month trials, AMITIZA and placebo groups showed a similar incidence of serious adverse events (one percent in both the AMITIZA and placebo groups) and related adverse events (22 percent in AMITIZA vs. 21 percent in the placebo group). The most common treatment-related adverse events (>4 percent of patients) were nausea (8 percent in the AMITIZA group vs. 4 percent in the placebo group), diarrhea (7 percent vs. 4 percent, respectively) and abdominal pain (5 percent vs. 5 percent, respectively).

Sucampo Pharmaceuticals is currently conducting additional trials with AMITIZA, including a clinical study for treatment of constipation in pediatric patients; a clinical study of AMITIZA in patients with hepatic impairment, and a full clinical development for the treatment of opioid-induced bowel dysfunction, with two pivotal Phase III efficacy and safety studies and one long-term safety study ongoing.

Source: Business Wire