OPKO’s Rayaldee Ph III trial meets primary endpoints in SHPT

US drugmaker OPKO Health (NYSE: OPK) has released positive top-line results from the first pivotal Phase III trial of Rayaldee, a first-in-class oral vitamin D prohormone treatment.

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 US Food and Drug Administration in August 2012.

A New Drug Application submission to the US Food and Drug Administration for Rayaldee is on track for the end of 2014, the company said. Top-line data from the second, identical pivotal Phase III trial are expected to be available in September.