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Sucampo Pharma Americas, LLC, a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), and its development and commercialization partner’s subsidiary Takeda Pharmaceuticals U.S.A., Inc. have announced that the New Drug Application (NDA) for the liquid formulation of AMITIZA (lubiprostone) 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.
Sucampo and Takeda announced topline results from a pharmacodynamic, PK and tolerability study of a liquid formulation of AMITIZA 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 of AMITIZA. As a result of this outcome 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 3 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 we have previously disclosed, our goals in developing a liquid formulation of AMITIZA are to help meet the needs of patients who will not take AMITIZA in its capsule form, as well as to support our pediatric clinical program,” said Peter Greenleaf, Sucampo’s Chief Executive Officer. “The FDA feedback and study results provide useful direction as we seek to develop an alternative formulation of AMITIZA for a wider range of patients who may need it.”
