Claims for Patent: 8,592,401

Summary for Patent: 8,592,401

Title:	Methods and compounds for vitamin D therapy
Abstract:	Methods and compositions comprising 1,25-dihydroxyvitamin D.sub.2 are disclosed. A method for lowering or maintaining lowered serum parathyroid hormone in human patients including administering to said patients an effective amount of 1,25-dihydroxyvitamin D.sub.2 to lower or maintain lowered serum parathyroid hormone levels is disclosed. Dosage forms and dosing regimens are also disclosed.
Inventor(s):	Petkovich; P. Martin (Kingston, CA), Bishop; Charles W. (Mount Horeb, WI), Messner; Eric J. (Lake Forest, IL), Crawford; Keith H. (Denver, CO)
Assignee:	Proventiv Therapeutics, LLC (Bannockburn, IL) Cytochroma Inc. (Markham, Ontario, CA)
Application Number:	12/597,224
Patent Claims:	1. A method for safely lowering or maintaining lowered serum intact parathyroid hormone in a human patient, comprising administering to the patient an effective amount of 1,25-dihydroxyvitamin D.sub.2 to lower or maintain lowered serum parathyroid hormone levels without causing substantially increased risk of hypercalcemia or hyperphosphatemia. 2. The method of claim 1, further comprising concurrently (a) increasing or maintaining serum calcium levels in the patient; (b) maintaining serum phosphorous levels in the patient; and (c) increasing or maintaining serum 1,25-dihydroxyvitamin D levels in the patient by said administration of 1,25-dihydroxyvitamin D.sub.2. 3. The method according to claim 2, comprising increasing or maintaining serum calcium levels in the patient in a range of about 8.6 to 10.2 mg/dL by said administration of 1,25-dihydroxyvitamin D.sub.2. 4. The method according to claim 2, comprising maintaining phosphorous levels in the patient in a range of 2.5 to 4.5 mg/dL by said administration of 1,25-dihydroxyvitamin D.sub.2. 5. The method according to claim 2, comprising increasing serum 1,25-dihydroxyvitamin D levels in the patient to the patient's normal historical physiological range by said administration of 1,25-dihydroxyvitamin D.sub.2. 6. The method according to claim 2, comprising maintaining serum 1,25-dihydroxyvitamin D levels in the patient's normal historical physiological range for at least 30 days by said administration of 1,25-dihydroxyvitamin D.sub.2. 7. The method according to claim 1, wherein said effective amount is sufficient to lower serum intact parathyroid hormone levels by at least 15%. 8. A method of safely increasing or maintaining blood concentrations of 1,25-dihydroxyvitamin D and maintaining serum calcium and phosphorous levels in a human patient with Chronic Kidney Disease by administering an amount of 1,25-dihydroxyvitamin D.sub.2 to the patient. 9. A method of alleviating one or more symptoms of 1,25-dihydroxyvitamin D deficiency in a human patient with Chronic Kidney Disease, comprising administering an amount of 1,25-dihydroxyvitamin D.sub.2 to the patient such that one or more symptoms of 1,25-dihydroxyvitamin D deficiency are alleviated and serum calcium and phosphorous levels are maintained. 10. The method of claim 9, wherein said one or more symptoms of 1,25-dihydroxyvitamin D deficiency comprise symptoms of deficiency in the non-classical effects of vitamin D. 11. The method of claim 10, wherein said administration of 1,25-dihydroxyvitamin D.sub.2 to the patient provides negative endocrine regulation of the renin-angiotensin system in the patient. 12. The method according to claim 1, wherein the patient has been diagnosed with chronic kidney disease (CKD). 13. The method according to claim 12, wherein the patient has been diagnosed with hyperparathyroidism secondary to chronic kidney disease (SHPT). 14. The method according to claim 12, wherein said CKD is Stage 1 or Stage 2 CKD. 15. The method according to claim 12, wherein said CKD is Stage 3, Stage 4, or Stage 5 CKD. 16. The method according to claim 15, wherein the amount of amount of 1,25-dihydroxyvitamin D.sub.2 administered is sufficient to reduce serum levels of PTH to 35-70 pg/mL for a Stage 3 CKD patient, to 70-110 pg/mL for a Stage 4 CKD patient, and to 150-300 pg/mL for a Stage 5 CKD patient. 17. The method according to claim 1, wherein the amount 1,25-dihydroxyvitamin D.sub.2 administered is in a range of 0.1 .mu.g per week to about 100 .mu.g per week. 18. The method according to claim 1, comprising administering 1,25-dihydroxyvitamin D.sub.2 for at least 30 days. 19. The method according to claim 18, comprising administering 1,25-dihydroxyvitamin D.sub.2 for at least 2 months. 20. The method according to claim 18, comprising administering 1,25-dihydroxyvitamin D.sub.2 for at least 6 months. 21. The method according to claim 18, further comprising avoiding progressive loss of 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D.sub.3 in the patient.

Details for Patent 8,592,401

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2027-04-25