IP Library Granted Patent US 7,772,210
Granted Patent B2
US 7,772,210 · App. 10/546,511 · Granted Aug 10, 2010

Cystitis treatment with high dose chondroitin sulfate

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Quick Facts
Patent No.
US 7,772,210
App. No.
10/546,511
Granted
Aug 10, 2010
Kind
B2
Abstract

Interstitial cystitis and related GAG-deficient conditions of the bladder and urinary tract are treated by instillation of high dose chondroitin sulfate, such as 400 mg/20 mL. The higher dose of chondroitin is effective for the rapid reduction of symptoms, particularly in patients with severe and otherwise recalcitrant cystitis.

Claims (23)

1. A method of treating cystitis in a subject, the method comprising treating the subject with a pharmaceutical composition comprising a unit dose of chondroitin sulfate in an amount from 350 mgs to 600 mgs, and an aqueous vehicle in a volume of from 10 mL to 100 mL, wherein the pharmaceutical composition is adapted for instillation to the bladder of a patient, so as to treat the cystitis in the subject.

2. The method according to claim 1 , wherein the chondroitin sulfate is present in an amount of 400 mg.

3. The method according to claim 1 , wherein the aqueous vehicle is present in an amount of 20 mL.

4. The method according to claim 1 , wherein the aqueous vehicle is phosphate buffered saline.

5. The method according to claim 1 , wherein the cystitis is interstitial cystitis.

6. The method according to claim 1 , wherein treating cystitis with the pharmaceutical composition comprises:

providing a subject afflicted with cystitis or a related condition, wherein a subject afflicted with a cystitis-related condition is identifiable as a subject that elicits one or more cystitis symptoms upon instillation of a potassium chloride solution; and

instilling the pharmaceutical composition into the bladder or urinary tract of the subject.

7. The method according to claim 6 , wherein the instilling is performed at least once weekly for a period of at least 6 weeks.

8. The method according to claim 6 , wherein the instilling is performed at least twice weekly for a period of at least 6 weeks.

9. The method according to claim 1 , wherein the pharmaceutical composition is essentially free from preservatives and other additives.

10. The method according to claim 1 , wherein the aqueous vehicle is present in a volume of from 10 mL to 40 mL.

11. The method according to claim 1 , wherein the pharmaceutical composition comprises a unit dose of 400 mgs of chondroitin sulfate in 20 mL of an aqueous vehicle.

12. The method according to claim 1 , wherein the pharmaceutical composition consists of a unit dose of 400 mgs of chondroitin sulfate and 20 mL of an aqueous vehicle.

13. The method according to claim 9 , wherein the pharmaceutical composition is contained within a vial.

14. The method according to claim 9 , wherein the pharmaceutical composition is pH 7.2, sterile, and contained within a vial.

15. The method according to claim 11 , wherein the pharmaceutical composition is essentially free from preservatives and other additives.

16. The method according to claim 1 , wherein the pharmaceutical composition is essentially free from preservatives and other additives, and comprises an aqueous vehicle present in a volume of from 10 mL to 40 mL.

17. The method according to claim 1 , wherein the chondroitin sulfate is present in an amount of from 375 mgs to 500 mgs.

18. The method according to claim 17 , wherein the aqueous vehicle is present in an amount of from 10 mL to 40 mL.

19. The method according to claim 18 , wherein the aqueous vehicle is phosphate buffered saline.

20. The method according to claim 18 , wherein the cystitis is interstitial cystitis.

21. A method of treating interstitial cystitis in a patient refractory to other forms of treatment, the method comprising administering to the patient by instillation a sterile pharmaceutical composition consisting of 400 mgs of chondroitin sulfate in a 20 mL aqueous vehicle, wherein the composition is administered twice weekly for 6 consecutive weeks.

Assignments (11)
RELEASE OF SECURITY INTEREST Recorded Mar 14, 2023
From: DEERFIELD PRIVATE DESIGN FUND III, L.P., AS AGENT
To: NUVO PHARMACEUTICALS INC.; ARALEZ PHARMACEUTICALS CANADA INC.; NUVO PHARMACEUTICALS (IRELAND) DESIGNATED ACTIVITY COMPANY (F/K/A NUVO PHARMACEUTICALS (IRELAND) LIMITED)
Reel/Frame 062974/0236 →
SECURITY INTEREST Recorded Dec 31, 2018
From: NUVO PHARMACEUTICALS INC.; NUVO PHARMACEUTICALS (IRELAND) DESIGNATED ACTIVITY COMPANY; ARALEZ PHARMACEUTICALS CANADA INC.
To: DEERFIELD PRIVATE DESIGN FUND III, L.P., AS AGENT
Reel/Frame 047875/0410 →
CHANGE OF NAME Recorded Mar 7, 2018
From: TRIBUTE PHARMACEUTICALS CANADA INC.
To: ARALEZ PHARMACEUTICALS CANADA INC.
Reel/Frame 045518/0563 →
RELEASE OF SECURITY INTEREST Recorded Feb 5, 2016
From: SWK FUNDING LLC
To: TRIBUTE PHARMACEUTICALS CANADA, INC.
Reel/Frame 037674/0301 →
RELEASE OF SECURITY INTEREST Recorded Aug 27, 2013
From: MIDCAP FUNDING III, LLC
To: TRIBUTE PHARMACEUTICALS CANADA INC.
Reel/Frame 031093/0486 →
SECURITY AGREEMENT Recorded Aug 8, 2013
From: TRIBUTE PHARACEUTICALS CANADA LLC
To: SWK FUNDING LLC
Reel/Frame 030988/0171 →
CONFIRMATION OF INTELLECTUAL PROPERTY SECURITY AGREEMENT RECORDED AT REEL 28275, FRAME 0357 Recorded Mar 20, 2013
From: TRIBUTE PHARMACEUTICALS CANADA INC.
To: MIDCAP FUNDING III, LLC, AS AGENT
Reel/Frame 030049/0126 →
MERGER Recorded Feb 21, 2013
From: STELLAR PHARMACEUTICALS INC.
To: TRIBUTE PHARMACEUTICALS CANADA INC.
Reel/Frame 029849/0376 →
SECURITY AGREEMENT Recorded May 25, 2012
From: STELLAR PHARMACEUTICALS INC.; TRIBUTE PHARMACEUTICALS CANADA LTD.; TRIBUTE PHARMA CANADA INC.
To: MIDCAP FUNDING III, LLC, AS AGENT
Reel/Frame 028275/0357 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2007
From: HAHN, SUNGTACK SAMUEL; RIEHL, PETER R.
To: STELLAR INTERNATIONAL INC.
Reel/Frame 019868/0463 →
MERGER Recorded Sep 24, 2007
From: STELLAR INTERNATIONAL INC.
To: STELLAR PHARMACEUTICALS INC.
Reel/Frame 019868/0757 →