IP Library Granted Patent US 8,168,597
Granted Patent B2
US 8,168,597 · App. 12/603,506 · Granted May 1, 2012

Method for treating cystic fibrosis

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Quick Facts
Patent No.
US 8,168,597
App. No.
12/603,506
Granted
May 1, 2012
Kind
B2
Abstract

The present invention is directed to a method for treating cystic fibrosis. The method comprises the steps of: identifying a patient suffering from cystic fibrosis, and administering to the patient an effective amount of denufosol or a pharmaceutically acceptable salt thereof and an effective amount of a macrolide. In one method, denufosol and the macrolide are administered by inhalation, preferably in a single formulation. In another method, denufosol is administered by inhalation and the macrolide is administered orally. The present invention is also directed to a pharmaceutical formulation comprising denufosol or a pharmaceutically acceptable salt thereof, a macrolide, and a pharmaceutically acceptable carrier. Preferred denufosol is denufosol tetrasodium and preferred macrolide is azithromycin. The pharmaceutical formulation preferably is in a form of an inhalable dry powder or in a liquid form.

Claims (17)

1. A method for treating cystic fibrosis, comprising the steps of:

identifying a patient suffering from cystic fibrosis,

administering to the patient an effective amount of denufosol or a pharmaceutically acceptable salt thereof and an effective amount of a macrolide.

2. The method according to claim 1 , wherein the denufosol is administered by inhalation.

3. The method according to claim 2 , wherein the macrolide is administered by oral administration or inhalation.

4. The method according to claim 1 , wherein said denufosol is denufosol tetrasodium.

5. The method according to claim 1 , wherein said denufosol and the macrolide are co-administered.

6. The method according to claim 1 , wherein said denufosol and the macrolide are co-administered in a single pharmaceutical formulation by inhalation.

7. The method according to claim 1 , wherein said macrolide is selected from the group consisting of azithromycin, clarithromycin, dirithromycin, erythromycin, and roxithromycin.

8. The method according to claim 7 , wherein said macrolide is azithromycin.

9. The method according to claim 1 , wherein the effective amount of denufosol is about 100-400 mg per day and an effective amount of a macrolide is 10-200 mg per day.

10. A pharmaceutical formulation comprising denufosol or a pharmaceutically acceptable salt thereof, a macrolide, and a pharmaceutically acceptable carrier.

11. The pharmaceutical formulation according to claim 10 , wherein said denufosol is denufosol tetrasodium and said macrolide is azithromycin.

12. The pharmaceutical formulation according to claim 10 , which is in a form of an inhalable dry powder.

13. The pharmaceutical formulation according to claim 12 , comprising about 30-130 mg of denufosol tetrasodium and about 3-70 mg of azithromycin in a unit dosage form.

14. The pharmaceutical formulation according to claim 10 , which is in a liquid form.

15. The pharmaceutical formulation according to claim 14 , comprising about 5-50 mg/mL of denufosol tetrasodium and about 0.5-8 mg/mL of azithromycin.

Assignments (3)
MERGER Recorded Aug 8, 2022
From: MERCK SHARP & DOHME CORP.
To: MERCK SHARP & DOHME LLC
Reel/Frame 061102/0145 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2015
From: INSPIRE PHARMACEUTICALS, INC.
To: MERCK SHARP & DOHME CORP.
Reel/Frame 034863/0372 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 30, 2009
From: KELLERMAN, DONALD J.; KRISHNAMOORTHY, RAMESH; BOYER, JOSE L.; SCHABERG, AMY E.
To: INSPIRE PHARMACEUTICALS, INC.
Reel/Frame 023719/0463 →