IP Library Granted Patent US 9,623,036
Granted Patent B2
US 9,623,036 · App. 15/009,712 · Granted Apr 18, 2017

Osteoclast inhibitors such as zoledronic acid for low back pain treatment

Inventors: Herriot Tabuteau (New York, NY); Jaro I. Karppinen (Oulu, FI)
Assignee: ANTECIP BIOVENTURES II LLC
A61K31/675A61K9/0053A61K9/2004A61K31/663
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Quick Facts
Patent No.
US 9,623,036
App. No.
15/009,712
Granted
Apr 18, 2017
Kind
B2
Abstract

Methods for the safe administration of imidazole or imidazolium compounds, and conditions that may be treated by these methods, are described herein.

Claims (33)

1. A method of treating Modic changes type I, comprising administering an osteoclast inhibitor to a mammal in need thereof, wherein the mammal experiences pain relief three months after the osteoclast inhibitor is administered; and

wherein the osteoclast inhibitor is zoledronic acid.

2. The method of claim 1 , wherein the osteoclast inhibitor is administered orally.

3. The method of claim 1 , wherein the Modic change is located at C1/2, C2/3, C3/4, C4/5, C5/6, or C6/7.

4. The method of claim 1 , wherein the Modic change is located at C7/T1, T112, T2/3, T3/4, T4/5, T5/6, T6/7, T7/8, T8/9, T9/10, T10/11, or T11/12.

5. The method of claim 1 , wherein the Modic change is located at T12/L1, L1/2, L2/3, L3/4, L4/5, or L5/S1.

6. The method of claim 1 , wherein the osteoclast inhibitor is administered weekly.

7. The method of claim 1 , wherein the osteoclast inhibitor is administered weekly for one or two months.

8. The method of claim 1 , wherein the osteoclast inhibitor is administered once a month or less frequently.

9. The method of claim 1 , wherein the osteoclast inhibitor is administered two to five times in a month.

10. The method of claim 1 , wherein the osteoclast inhibitor is administered daily.

11. The method of claim 10 , wherein the osteoclast inhibitor is orally administered for five to ten consecutive days.

12. The method of claim 1 , wherein the mammal achieves a reduction relative to baseline in the size of the Modic change of at least about 5%.

13. A method of treating Modic changes type I, comprising orally administering about 10 mg to about 600 mg of an osteoclast inhibitor to a mammal in need thereof, wherein the mammal experiences pain relief three months after the osteoclast inhibitor is administered; and

wherein the osteoclast inhibitor is zoledronic acid.

14. The method of claim 13 , wherein the Modic change is located at C1/2, C2/3, C3/4, C4/5, C5/6, or C6/7.

15. The method of claim 13 , wherein the Modic change is located at C7/T1, T1/2, T2/3, T3/4, T4/5, T5/6, T6/7, T7/8, T8/9, T9/10, T10/11, or T11/12.

16. The method of claim 13 , wherein the Modic change is located at T12/L1, L1/2, L2/3, L3/4, L4/5, or L5/S1.

17. The method of claim 13 , wherein the osteoclast inhibitor is administered daily, weekly, or monthly.

18. The method of claim 13 , wherein the osteoclast inhibitor is administered once a month or less frequently.

19. The method of claim 13 , wherein the osteoclast inhibitor is administered in at least two divided doses.

20. The method of claim 13 , wherein the mammal achieves a reduction relative to baseline in the size of the Modic change of at least about 5%.

21. A method of treating pain associated with Modic changes type I, comprising administering about 200 mg to about 400 mg of an osteoclast inhibitor in at least two divided doses to a mammal in need thereof, wherein the mammal experiences pain relief three months after the osteoclast inhibitor is administered; and

wherein the osteoclast inhibitor is zoledronic acid.

22. The method of claim 21 , wherein the osteoclast inhibitor is administered orally.

23. The method of claim 21 , wherein the bioavailability of the osteoclast inhibitor is about 0.1% to about 5%.

24. The method of claim 21 , wherein the osteoclast inhibitor is administered daily, weekly, or monthly.

25. The method of claim 24 , wherein the osteoclast inhibitor is administered daily for about five to about fifteen consecutive days.

26. The method of claim 24 , wherein the osteoclast inhibitor is administered weekly at least twice.

27. The method of claim 24 , wherein the osteoclast inhibitor is administered monthly at least twice.

28. The method of claim 21 , wherein zoledronic acid is in the disodium salt form.

29. The method of claim 21 , wherein the Modic change is located in the low back.

30. The method of claim 21 , wherein the mammal has Modic changes at two or more levels.

Assignments (2)
CORRECTIVE ASSIGNMENT TO ADD TWO ASSIGNOR'S DATA PREVIOUSLY RECORDED ON REEL 042338 FRAME 0844. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 22, 2017
From: TABUTEAU, HERRIOT; KARPPINEN, JARO I.; AXSOME THERAPEUTICS, INC.
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 042957/0560 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2017
From: TABUTEAU, HERRIOT; JONES, GRAEME
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 042338/0844 →
Continuity (5)
Division 14639013 · Mar 4, 2015
Continuation In Part 14604524 · Jan 23, 2015
Continuation In Part PCTUS2014050427 · Aug 8, 2014
Provisional Application 62127214 · Mar 2, 2015
Related Publication 20160166589A1 · Jun 16, 2016