Opko's Rayaldee meets in secondary hyperparathyroidism trial

Opko Health Inc. (NYSE:OPK) said Rayaldee ( CTAP101) met the primary endpoint of improving the response rate vs. placebo in a Phase III trial to treat secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients (p<0.001). The double-blind trial enrolled 213 pre-dialysis, stage 3 or stage 4 CKD patients with vitamin D insufficiency.

Data from an identical Phase III trial are expected in September, with an NDA submission for Rayaldee in the indication slated for year end. Rayaldee is a modified-release formulation of 25-hydroxyvitamin D. ...