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news.Amitiza (lubiprostone) has demonstrated long-term safety and tolerability profiles in patients with irritable bowel syndrome with constipation (IBS-C), according to a study.
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Amitiza is indicated for the treatment of chronic idiopathic constipation and for IBS-C.
The open-label extension Phase 3 study was conducted by Takeda Pharmaceuticals USA, and Sucampo Pharmaceuticals to evaluate the effects of Amitiza in patients with IBS-C for up to 52 weeks.
Patients with IBS-C show less than three spontaneous bowel movements per week, greater than 25% hard stools, and greater than 25% of spontaneous bowel movements associated with straining.
The trial’s primary objective was to determine the long-term safety and tolerability profiles of Amitiza when administered twice-daily for 36 weeks.
The study results indicated that Amitiza, when administered to IBS-C patients for up to 13 months, continued to show an acceptable safety and tolerability profile.
University of Illinois College of Medicine clinical associate and professor of medicine John F Johanson said Amitiza is the only drug approved for IBS-C in adult women, and has an established safety and tolerability profile.
"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," Johanson added.