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Phase 3 Long-Term Safety Trial Results of Lubiprostone in Patients with Irritable Bowel Syndrome with Constipation was Recently Published in Alimentary Pharmacology and Therapeutics


A recently published study in the journal Alimentary Pharmacology and Therapeutics, demonstrated the long-term safety and tolerability profiles of AMITIZA (lubiprostone) in patients with irritable bowel syndrome with constipation (IBS-C). This study, initiated by Takeda Pharmaceuticals U.S.A., Inc. and Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), was designed to determine the effects of AMITIZA in patients with IBS-C for up to 52 weeks.

The primary objective of this open-label, extension study (n=520) was to determine the long-term safety and tolerability profiles of AMITIZA when administered twice-daily for 36 weeks (8 mcg twice-daily) to patients with IBS-C. Results indicated that AMITIZA, when administered to IBS-C patients for up to 13 months, continues to demonstrate an acceptable safety and tolerability profile.

“It is important to note that IBS-C is a chronic, long-term condition. Given that AMITIZA is the only drug approved for IBS-C in adult women, it is important to know that it has an established safety and tolerability profile,” said John F. Johanson, MD, MSc, FACP, FACG, Clinical Associate Professor of Medicine, University of Illinois College of Medicine. “Since many of those suffering may be receiving long-term treatment, it is important to have such encouraging data published on the only drug approved for IBS-C in adult women.”

Posted-In: News FDA


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