IP Library Granted Patent US 10,016,445
Granted Patent B2
US 10,016,445 · App. 15/808,794 · Granted Jul 10, 2018

Compositions for oral administration of zoledronic acid or related compounds for treating complex regional pain syndrome

Inventor: Herriot Tabuteau (New York, NY)
Assignee: ANTECIP BIOVENTURES II LLC
A61K31/663A61K9/0019A61K9/0053A61K9/0056A61K9/2004A61K31/573A61K31/675A61K45/06
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Quick Facts
Patent No.
US 10,016,445
App. No.
15/808,794
Granted
Jul 10, 2018
Kind
B2
Abstract

Oral dosage forms of osteoclast inhibitors, such as zoledronic acid, in an acid or a salt form can be used to treat or alleviate pain or related conditions, such as complex regional pain syndrome.

Claims (30)

1. A method of treating complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being receives a total of about 100 mg to about 350 mg of the zoledronic acid in at least two divided doses that are orally administered within a period of six months, and wherein the human being has suffered a traumatic event to incite the complex regional pain syndrome.

2. The method of claim 1 , wherein the zoledronic acid is orally administered within a period of one or two months.

3. The method of claim 1 , wherein the human being receives at least three doses of the zoledronic acid.

4. The method of claim 3 , wherein the zoledronic acid is orally administered three to five times a month.

5. The method of claim 1 , wherein the human being receives at least six doses of the zoledronic acid.

6. The method of claim 5 , wherein the zoledronic acid is not administered more frequently than weekly.

7. The method of claim 1 , wherein three doses for a total amount of at least about 125 mg of the zoledronic acid are orally administered within a period of two months.

8. A method of treating pain associated with complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being receives at least two divided doses of about 20 mg to about 100 mg per dose of the zoledronic acid and no more than a total amount of about 500 mg of the zoledronic acid within a period of six months, and wherein the human being has suffered a traumatic event to precipitate the complex regional pain syndrome.

9. The method of claim 8 , wherein the human being receives two doses to eight doses of the zoledronic acid within a period of four months.

10. The method of claim 9 , wherein each dose comprises about 20 mg to about 60 mg of the zoledronic acid.

11. The method of claim 9 , wherein each dose comprises about 35 mg to about 60 mg of the zoledronic acid.

12. The method of claim 8 , wherein the human being experiences pain relief for at least 48 hours.

13. The method of claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 24-hour sustained plasma level factor that is at least twice that of 1 mg of zoledronic acid administered intravenously.

14. The method of claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 48-hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.

15. The method of claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 24-hour sustained plasma level factor that is at least 1.2 times that of 4 mg of zoledronic acid administered intravenously.

16. The method of claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 48-hour sustained plasma level factor that is at least twice that of 1 mg of zoledronic acid administered intravenously.

17. A method of treating complex regional pain syndrome comprising orally administering a total of about 100 mg to about 400 mg of zoledronic acid within a period of six months to a human being in need thereof.

18. method of claim 17 , wherein the human being receives about 250 mg to about 300 mg of the zoledronic acid within a period of six months.

19. The method of claim 17 , wherein the human being experiences at least 48 hours of pain relief.

20. The method of claim 17 , wherein the human being fasts for at least 30 minutes after the zoledronic acid is orally administered.

21. The method of claim 17 , wherein the human being fasts for at least 30 minutes before the zoledronic acid is orally administered.

22. The method of claim 18 , wherein the zoledronic acid is orally administered for one to three months.

23. The method of claim 17 , wherein the zoledronic acid is orally administered weekly.

24. The method of claim 18 , wherein the zoledronic acid is orally administered weekly for one to two months.

25. The method of claim 24 , wherein at least 100 mg of the zoledronic acid is orally administered within the first month of treatment.

26. The method of claim 23 , wherein the zoledronic acid is orally administered two to four times in one month.

27. The method of claim 26 , wherein about 10 mg to about 100 mg of the zoledronic acid is orally administered in a weekly dose.

28. The method of claim 23 , wherein the zoledronic acid is orally administered for two to eight times in two months.

29. The method of claim 28 , wherein about 10 mg to about 100 mg of zoledronic acid is orally administered in a weekly dose.

30. The method of claim 17 , wherein the zoledronic acid is orally administered in a dosage form containing at least 30% zoledronic acid.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2018
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 045034/0542 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2017
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 044777/0488 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 16, 2017
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 044156/0719 →
Continuity (28)
Continuation In Part 15587108 · May 4, 2017
Continuation In Part 15349926 · Nov 11, 2016
Continuation 15217752 · Jul 22, 2016
Continuation 14967224 · Dec 11, 2015
Continuation 14604524 · Jan 23, 2015
Continuation In Part 14536526 · Nov 7, 2014
Continuation In Part 14446184 · Jul 29, 2014
Division 14288716 · May 28, 2014
Continuation In Part 14279229 · May 15, 2014
Continuation 14063979 · Oct 25, 2013
Continuation In Part 13894274 · May 14, 2013
Continuation In Part PCTUS2015032739 · May 27, 2015
Continuation PCTUS2014050427 · Aug 8, 2014
Continuation 14279241 · May 15, 2014
Provisional Application 61933608 · Jan 30, 2014
Provisional Application 61803721 · Mar 20, 2013
Provisional Application 61767647 · Feb 21, 2013
Provisional Application 61767676 · Feb 21, 2013
Provisional Application 61764563 · Feb 14, 2013
Provisional Application 61762225 · Feb 7, 2013
Provisional Application 61655541 · Jun 5, 2012
Provisional Application 61655527 · Jun 5, 2012
Provisional Application 61654383 · Jun 1, 2012
Provisional Application 61654292 · Jun 1, 2012
Provisional Application 61647478 · May 15, 2012
Provisional Application 61646538 · May 14, 2012
Provisional Application 62378140 · Aug 22, 2016
Related Publication 20180064735A1 · Mar 8, 2018