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Rockwell Medical Inc Announces SFP Meets Primary and Key Secondary Endpoints In Phase 3 CRUISE-2 Efficacy Study


Wednesday, 4 Sep 2013 07:45am EDT 

Rockwell Medical Inc announced top-line results from the long-term CRUISE-2 Phase 3 efficacy study of SFP. SFP is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. In this study, SFP met the primary endpoint, demonstrating a statistically mean change in hemoglobin from baseline to End-of-Treatment. Additionally, SFP met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term study is the second and final study of two identical Phase 3 efficacy studies to provide clinical data required for the Company to file a New Drug Application (NDA) with the U.S. FDA. 

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26 Dec 2014