Amitiza fails Phase III trial for CI Constipation - Sucampo/Takeda
Sucampo and Takeda announced topline results from a pharmacodynamic, PK and tolerability Phase III study of a liquid formulation of Amitiza (lubiprostone) in adults with Chronic Idiopathic Constipation (CIC). The study showed directional improvement in spontaneous bowel movement (SBM) frequency in favor of liquid Amitiza compared to placebo, but did not reach statistical significance.
The safety profile observed in this study was consistent with previous clinical studies. In conjunction with the FDA feedback, Sucampo and Takeda are now assessing next steps, which may include formulation modification. The companies are also evaluating potential impact to the timing of initiation of the second pivotal trial in the global, multicenter Phase III program for pediatric functional Constipation in children aged 6 months to less than 6 years, as the liquid formulation would be required for this study.
As a result, the companies have announced that the New Drug Application for the liquid formulation of Amitiza will not be filed in the second half of 2014. In preliminary pre-NDA meeting comments, the FDA informed Sucampo that it would require additional data to characterize pharmacokinetics (PK) of the new formulation.
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