Neridronic acid for treating complex regional pain syndrome

• US 9,707,245 B2
• Filed: 11/21/2016
• Issued: 07/18/2017
• Est. Priority Date: 05/14/2012
• Status: Active Grant

• Current Assignee: Antecip Bioventures II LLC
• Original Assignee: Antecip Bioventures II LLC
• Inventors: Tabuteau, Herriot
• Primary Examiner(s): HUI, SAN MING R
• Application Number:
  US15/357,932
• Publication Number:
  US 20170065621A1
• Time in Patent Office: 239 Days
• Field of Search: 514 76, 514141
• CPC Class Codes: A61K 31/663 Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients

Abstract

Oral dosage forms of osteoclast inhibitors, such as nitrogen-containing bisphosphonates, can be used to treat or alleviate pain or related conditions such as complex regional pain syndrome.

Claims

1. A method of treating pain associated with complex regional pain syndrome (CRPS) comprising administering neridronic acid to a human being with CRPS, wherein bone fracture was a predisposing event for CRPS, and wherein the neridronic acid is in a salt or an acid form.

2. The method of claim 1, wherein the CRPS is CRPS type I.

3. The method of claim 1, wherein the neridronic acid is in a salt form.

4. The method of claim 1, wherein the neridronic acid is administered intravenously.

5. The method of claim 1, wherein the neridronic acid is administered orally.

6. The method of claim 5, wherein a total of about 50 mg to about 500 mg of the neridronic acid is administered daily.

7. The method of claim 5, wherein a total of about 100 mg to about 500 mg of the neridronic acid is administered daily.

8. The method of claim 5, wherein a total of about 150 mg to about 300 mg of the neridronic acid is administered daily.

9. The method of claim 1, wherein the neridronic acid is administered parenterally.

10. The method of claim 9, wherein a total of about 5 mg to about 500 mg of the neridronic acid is administered within one month.

11. The method of claim 9, wherein a total of about 5 mg to about 200 mg of the neridronic acid is administered within one month.

12. The method of claim 9, wherein each dose contains about 10 mg to about 150 mg of the neridronic acid.

13. The method of claim 9, wherein a total of about 100 mg to about 300 mg of the neridronic acid is administered within one month.

14. The method of claim 1, wherein a total of about 100 mg to about 600 mg of the neridronic acid is administered.

15. The method of claim 1, wherein a total of about 100 mg to about 300 mg of the neridronic acid is administered.

16. The method of claim 4, wherein each dose contains about 10 mg to about 150 mg of the neridronic acid.

17. The method of claim 4, wherein each dose contains about 100 mg of the neridronic acid.

18. The method of claim 17, wherein the neridronic acid is administered at least four times.

19. The method of claim 4, wherein each dose contains about 50 mg to about 65 mg of the neridronic acid.

20. The method of claim 19, wherein the neridronic acid is administered about every three days.

21. The method of claim 5, wherein each dose contains about 100 mg of the neridronic acid.

22. The method of claim 3, wherein each dose contains an equivalent of about 50 mg to about 60 mg of the neridronic acid.

23. The method of claim 1, wherein the neridronic acid is administered about once daily to about once weekly.

24. The method of claim 1, wherein the neridronic acid is administered in a single or in divided doses.

25. The method of claim 21, wherein about four doses of about 100 mg of the neridronic acid are administered.

26. The method of claim 1, wherein the neridronic acid is administered weekly for about four to about six weeks.

27. The method of claim 1, wherein the human being is at least 18 years of age.

28. The method of claim 27, wherein the human being is at least 40 years of age.

29. The method of claim 27, wherein the human being has a baseline pain intensity score of at least 4 on the 0-10 Numeric Rating Scale.

30. The method of claim 1, wherein the CRPS is CRPS type II.