Rayaldee meets endpoints in Phase III trial for CKD-OPKO Health

OPKO Health has announced successful top-line results from the second and final pivotal Phase III trial of Rayaldee as a new treatment for secondary Hyperparathyroidism in patients with stage 3 or 4 Chronic Kidney Disease (CKD) and vitamin D insufficiency. This trial is the second of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of Rayaldee. This trial involved 216 adult patients recruited from 38 sites throughout the U.S. The completed trial successfully met all primary efficacy and safety endpoints. The primary efficacy endpoint was a responder analysis in which �responder� was defined as any treated subject who demonstrated an average 30% decrease in plasma parathyroid hormone from pre-treatment baseline during the last six weeks of the treatment period.

A significantly higher response rate was observed with Rayaldee which steadily increased with treatment duration. The response rate with Rayaldee was similar in CKD stages 3 and 4. Safety and tolerability data were comparable in both treatment groups. Patients who completed the two pivotal trials are being treated, at their election, for an additional 6 months with Rayaldee during an open-label extension study. A New Drug Application submission to the FDA is planned for the end of 2014.