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www.fdanews.com/articles/178414-phase-iv-trial-confirms-veltassa-can-be-taken-with-or-without-food

Phase IV Trial Confirms Veltassa Can Be Taken With or Without Food

September 14, 2016

Relypsa announced positive results from a Phase IV study of Veltassa (patiromer) for oral suspension given with or without food for the treatment of hyperkalemia. Currently, Veltassa’s prescribing information requires it to be taken with food.

The post-market study met its primary endpoint and demonstrated no statistically significant difference in the percentage of patients that achieved either week 3 or 4 serum potassium in the target range of 3.8-5.0 mEq/L, regardless of whether it was taken with food. Relypsa is planning to share the data with the FDA, and present it at an upcoming medical meeting.

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