IP Library › Granted Patent US 9,504,661
Granted Patent B2
US 9,504,661 · App. 14/063,841 · Granted Nov 29, 2016

Dapsone to treat rosacea

Inventor: John S. Garrett (Fort Collins, CO)
Assignee: Allergan, Inc.
A61K31/145A61K8/46A61K9/0048A61K9/06A61K31/4164A61K47/32A61Q19/00
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Quick Facts
Patent No.
US 9,504,661
App. No.
14/063,841
Granted
Nov 29, 2016
Kind
B2
Abstract

The methods described herein provide treatment of rosacea using topical formulations of dapsone. The methods also provide treatment of rosacea with topical dapsone in combination with other active agents, including metronidazole. The methods avoid negative hematologic side effects, including hemolysis and hemolytic anemia, that are associated with oral administration of dapsone.

Claims (14)

1. A method to treat mild to severe papulopustular rosacea comprising topically administering to a patient in need thereof an effective amount of a first pharmaceutical composition comprising dapsone and a pharmaceutically acceptable carrier, wherein said first pharmaceutical composition is a semisolid aqueous gel;

wherein the pharmaceutical composition is administered twice daily; and

wherein said method further comprises administering a second composition comprising metronidazole and a pharmaceutically acceptable carrier.

2. The method of claim 1 wherein the patient has an Investigator Global Assessment score of 3 or higher before treatment.

3. The method of claim 1 wherein treatment results in a mean reduction of at least 13 papulopustular lesions.

4. The method of claim 1 wherein treatment results in a mean reduction of at least 43% of the papulopustular lesions.

5. The method of claim 1 wherein the patient has 20 or more inflammatory lesions.

6. The method of claim 1 wherein the first pharmaceutical composition additionally comprises a thickening agent, a high-boiling, nonionic organic solvent, a preservative, or a base agent.

7. The method of claim 1 wherein the dapsone comprises about 0.5 wt % to 10 wt % of the pharmaceutical composition.

8. The method of claim 1 wherein the dapsone is present in both a microparticulate state and a dissolved state.

9. The method of claim 8 wherein the microparticulate dapsone is a crystalline precipitate.

10. The method of claim 8 wherein the microparticulate dapsone is an amorphous precipitate.

11. The method of claim 1 wherein the pharmaceutical composition further comprises an antioxidant, a fragrance, a colorant, a sunscreen, or combinations thereof.

12. The method of claim 1 wherein the pharmaceutical composition comprises about 5 wt % dapsone, about 0.85 wt % carbomer 980, about 25 wt % diethylene glycol monoethyl ether (DGME), about 0.2 wt % methylparaben, about 0.2 wt % sodium hydroxide; and about 68.75 wt % purified water.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2015
From: GARRETT, JOHN S.
To: ALLERGAN, INC.
Reel/Frame 035268/0162 →
Continuity (2)
Division 12305413
Related Publication 20140050680A1 · Feb 20, 2014