Claims for Patent: 10,302,660

Summary for Patent: 10,302,660

Title:	Methods useful for vitamin D deficiency and related disorders
Abstract:	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.
Inventor(s):	Petkovich; P. Martin (Kingston, CA), Helvig; Christian F. (Markham, CA), Melnick; Joel Z. (Wilmette, IL)
Assignee:	OPKO RENAL, LLC (Miami, FL) OPKO IRELAND GLOBAL HOLDINGS, LTD. (Grand Cayman, KY)
Application Number:	15/357,059
Patent Claims:	1. An extended release pharmaceutical formulation comprising a CYP24 inhibitor and a vitamin D prohormone. 2. The formulation of claim 1, wherein the CYP24 inhibitor is a pure inhibitor of CYP24 or a dual-action CYP24 inhibitor/VDR agonist. 3. The formulation of claim 1, wherein the CYP24 inhibitor is selected from 23,23-difluoro-24-sulfone vitamin D.sub.3 compounds, 25-sulfone vitamin D.sub.3 compounds, 24,24-difluoro-25-sulfone vitamin D.sub.3 compounds, 24-sulfoximine vitamin D.sub.3 compounds, 16-ene-25-oxime vitamin D.sub.3 compounds, and 16-ene-25-oxime ether vitamin D.sub.3 compounds, 24-sulfone vitamin D.sub.3 compounds, and 24,24-difluoro vitamin D.sub.3 compounds. 4. The formulation of claim 1, wherein the vitamin D prohormone is selected from 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, and combinations thereof. 5. The formulation of claim 4, wherein the vitamin D prohormone is 25-hydroxyvitamin D.sub.3. 6. The formulation of claim 1, wherein the formulation is for oral administration. 7. The formulation of claim 1, further comprising an oil. 8. The formulation of claim 7, further comprising esters of fatty acids. 9. The formulation of claim 8, wherein the esters of fatty acids are fatty acid glycerides. 10. The formulation of claim 1, wherein the formulation comprises a capsule. 11. A method of treating vitamin D deficiency in a patient comprising administering to the patient an effective amount of the formulation of claim 1 to increase to or maintain serum 25-hydroxyvitamin D at a level of at least 30 ng/m L. 12. The method of claim 11, wherein the CYP24 inhibitor is a pure inhibitor of CYP24 or a dual-action CYP24 inhibitor/VDR agonist. 13. The method of claim 11, wherein the CYP24 inhibitor is selected from 23,23-difluoro-24-sulfone vitamin D.sub.3 compounds, 25-sulfone vitamin D.sub.3 compounds, 24,24-difluoro-25-sulfone vitamin D.sub.3 compounds, 24-sulfoximine vitamin D.sub.3 compounds, 16-ene-25-oxime vitamin D.sub.3 compounds, and 16-ene-25-oxime ether vitamin D.sub.3 compounds, 24-sulfone vitamin D.sub.3 compounds, and 24,24-difluoro vitamin D.sub.3 compounds. 14. The method of claim 11, wherein the vitamin D prohormone is selected from 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, and combinations thereof. 15. The method of claim 14, wherein the vitamin D prohormone is 25-hydroxyvitamin D.sub.3. 16. The method of claim 11, wherein the extended release formulation is administered orally. 17. The method of claim 11, wherein the extended release formulation comprises an oil. 18. The method of claim 17, wherein the extended release formulation comprises esters of fatty acids. 19. The method of claim 18, wherein the esters of fatty acids are fatty acid glycerides. 20. The method of claim 11, wherein the extended release formulation comprises a capsule. 21. The method of claim 11, wherein the patient has secondary hyperparathyroidism. 22. The method of claim 11, wherein the patient has Chronic Kidney Disease Stage 1 or Stage 2. 23. The method of claim 11, wherein the patient has Chronic Kidney Disease Stage 3 or Stage 4. 24. The method of claim 11, wherein the patient has Chronic Kidney Disease Stage 5. 25. A method of treating secondary hyperparathyroidism in a patient having Chronic Kidney Disease (CKD) comprising administering an effective amount of the formulation of claim 1 to lower serum parathyroid hormone. 26. The method of claim 25, wherein the CYP24 inhibitor is a pure inhibitor of CYP24 or a dual-action CYP24 inhibitor/VDR agonist. 27. The method of claim 25, wherein the CYP24 inhibitor is selected from 23,23-difluoro-24-sulfone vitamin D.sub.3 compounds, 25-sulfone vitamin D.sub.3 compounds, 24,24-difluoro-25-sulfone vitamin D.sub.3 compounds, 24-sulfoximine vitamin D.sub.3 compounds, 16-ene-25-oxime vitamin D.sub.3 compounds, and 16-ene-25-oxime ether vitamin D.sub.3 compounds, 24-sulfone vitamin D.sub.3 compounds, and 24,24-difluoro vitamin D.sub.3 compounds. 28. The method of claim 25, wherein the vitamin D prohormone is selected from 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, and combinations thereof. 29. The method of claim 28, wherein the vitamin D prohormone is 25-hydroxyvitamin D.sub.3. 30. The method of claim 25, wherein the extended release formulation is administered orally. 31. The method of claim 25, wherein the extended release formulation comprises an oil. 32. The method of claim 31, wherein the extended release formulation comprises esters of fatty acids. 33. The formulation of claim 32, wherein the esters of fatty acids are fatty acid glycerides. 34. The method of claim 25, wherein the extended release formulation comprises a capsule. 35. The method of claim 25, wherein the patient has Chronic Kidney Disease Stage 1 or Stage 2. 36. The method of claim 25, wherein the patient has Chronic Kidney Disease Stage 3 or Stage 4. 37. The method of claim 25, wherein the patient has Chronic Kidney Disease Stage 5.

Details for Patent 10,302,660

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2028-04-02