BioCentury
ARTICLE | Clinical News

Liquid lubiprostone regulatory update

March 24, 2014 7:00 AM UTC

Sucampo and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan) said the partners will not submit an NDA to FDA in 2H14 for a liquid formulation of Amitiza lubiprostone to treat chronic idiopathic constipation (CIC) after the agency indicated in a preliminary pre-NDA meeting that it would require additional pharmacokinetic data. Sucampo also said that top-line data from a pharmacodynamic, pharmacokinetic and safety trial in adults with CIC showed that liquid Amitiza did not significantly improve spontaneous bowel movement (SBM) frequency vs. placebo. As a result of the data and meeting, Sucampo and Takeda are assessing next steps, which may include modifying the formulation.

The companies are also evaluating the potential effect to the start of a second Phase III trial of lubiprostone for pediatric functional constipation in children ages 6 months to >6 years, which would have used the liquid formulation. The partners began a Phase III trial with the capsule formulation of lubiprostone for the indication in children ages 6-17 years (see BioCentury, Dec. 23, 2013). ...