Amitiza lubiprostone: Phase III started

Sucampo and Takeda began a double-blind, placebo-controlled, international Phase III trial to evaluate 12 or 24 µg oral lubiprostone twice daily for 12 weeks in >500 patients ages 6-17 years with functional constipation. The companies' Phase III program for lubiprostone in pediatric functional constipation will comprise 2 double-blind, placebo-controlled trials and 2 long-term safety extension studies. Sucampo plans to submit an sNDA for lubiprostone to treat pediatric functional constipation by early 2016. ...