OPKO Health Says Rayaldee Phase 3 Trial Meets Primary Endpoints

(RTTNews) - OPKO Health, Inc. (OPK) on Monday 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 in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

The completed trial successfully met all primary efficacy and safety endpoints. Safety and tolerability data were comparable in both treatment groups.

Top-line data from the second, identical pivotal phase 3 trial are expected to be available in September.

Patients completing the two pivotal trials are being treated, at their election, for an additional 6 months with Rayaldee during an ongoing open-label extension study. Enrollment in that extension study surpassed the targeted level of 270 patients by May 2014 and 141 patients have completed participation.

A New Drug Application submission to the U.S. FDA is on track for the end of 2014, the company said.