Opko Ireland Global Holdings, Limited

Eirgen Pharma Ltd.

Opko Renal, LLC

Opko IP Holdings Ii, Inc.

Joel Z Melnick

Jay A White

Samir P Tabash

P Martin Petkovich

Charles W Bishop

Stephen A Strugnell

Sammy Asiamah Agudoawu

Susan Peers

Christian F Helvig

Eric J Messner

Sammy A Agudoawu

A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation can comprise one or both of 25-hydroxyvitamin Dand 25-hydroxyvitamin Dand a stabilizing compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.

Stabilized modified release vitamin D formulation and method of administering same

Methods for treating vitamin D insufficiency and secondary hyperparathyroidism in patients having CKD comprising administering repeat doses of 25-hydroxyvitamin D are disclosed. The methods comprise administering 25-hydroxyvitamin D in an amount effective to safely raise the patient's serum 25-hydroxyvitamin D level to greater than 90 ng/ml and/or to control the patient's serum ratio of 25-hydroxyvitamin D to 24,25-dihydroxyvitamin D to less than 20.

Methods of vitamin D treatment

Methods, compositions, and kits for adjunctive therapy using 25-hydroxyvitamin D are disclosed. The 25-hydroxyvitamin D may be administered with an agent that increases the risk of hypocalcemia, such as cinacalcet or a salt thereof, and/or an anticancer agent. The adjunctive therapy is effective to treat and prevent iatrogenic hypocalcemia and/or secondary hyperparathyroidism, as well as delay cancer progression and the time to a post-treatment skeletal related event.

Adjunctive therapy with 25-hydroxyvitamin D and articles therefor

Methods and compositions for reducing serum parathyroid levels in, for example, chronic kidney disease patients are disclosed. In these methods, an effective amount of a modified release formulation of 25-hydroxy vitamin D is orally administered to a patient suffering from secondary hyperparathyroidism to lower the patient's serum intact parathyroid hormone (iPTH) level, while avoiding a surge in serum total 25-hydroxy vitamin D.

Methods and compositions for reducing parathyroid levels

A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin Dand 25-hydroxyvitamin Dand a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.

Stabilized modified release Vitamin D formulation and method of administering same

Methods of treating vitamin D insufficiency in chronic kidney disease

Methods for diagnosing, treating, and preventing catabolism-related vitamin D deficiency and related disorders, related compositions, apparatus and kits, are disclosed. A method involves measuring CYP24 expression and/or activity, or a proxy thereof such as FGF23 level, in a patient and correlating abnormally elevated CYP24 expression and/or activity with catabolism-related vitamin D deficiency or with susceptibility for catabolism-related vitamin D deficiency. In response to abnormally elevated CYP24 expression and/or activity, the method further includes administering a CYP24 inhibitor to the vitamin D deficient or at-risk patient, and preferably avoiding activation of the vitamin D binding receptor, such as by avoiding administration of active vitamin D compounds to such patients. Optionally, a vitamin D prohormone or prohormone can be administered.

Growing community of inventors

Wilmette, IL, United States of America

Joel Z Melnick