OPKO Health's Rayaldee Meets Primary Endpoints Of Late-Stage Study

(RTTNews) - OPKO Health Inc. (OPK) Tuesday said the advanced study of Rayaldee as a treatment for secondary hyperparathyroidism in patients with chronic kidney disease and vitamin D insufficiency has met its primary endpoints.

The second and final pivotal phase 3 trial intended to establish the safety and efficacy of Rayaldee as a new treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

Secondary Hyperparathyroidism or SHPT is a condition commonly associated with chronic kidney disease in which the parathyroid glands secrete excessive amounts of plasma parathyroid hormone or PTH. SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, and PTH secretion.

"Top-line data from this second study confirmed that Rayaldee effectively controls secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease by correcting vitamin D insufficiency," said Joel Melnick, Vice President of Clinical Research and Development for OPKO's Renal Division. "As with the first trial, Rayaldee was equally effective in both disease stages, indicating that this new therapy is appropriate even for patients with minimal functioning kidney mass."

A New Drug Application submission to the FDA is planned for the end of 2014, the company said in a statement.

OPK is currently trading at $8.39, up $0.10 or 1.21%, on the NYSE.