MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE: OPK), announced successful top-line results from the first pivotal phase 3 trial of Rayaldee™. This trial is one of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of Rayaldee as a new treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. Both trials are the subject of a Special Protocol Assessment (SPA) established with the United States (U.S.) Food and Drug Administration (FDA) in August 2012.
“Top-line data from this study demonstrate that Rayaldee effectively controls secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease by correcting vitamin D insufficiency,” stated Joel Z. Melnick, MD, Vice President of Clinical Research and Development for OPKO’s Renal Division. “Rayaldee was equally effective in both disease stages, indicating that this new therapy is appropriate even for patients with minimal functioning kidney mass.”
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