IP Library Granted Patent US 10,792,289
Granted Patent B2
US 10,792,289 · App. 16/263,886 · Granted Oct 6, 2020

Use of aerosolized levofloxacin for treating cystic fibrosis

Inventors: Jeffery S. Loutit (Los Altos, CA); Elizabeth E. Morgan (Escondido, CA); Michael N. Dudley (San Diego, CA); David C. Griffith (San Marcos, CA); Olga Lomovskaya (Mountain View, CA)
Assignee: Horizon Orphan LLC
A61K31/5383A61K9/0078A61K9/08A61K33/06A61K33/14A61K45/06Y02A50/401Y02A50/469Y02A50/47Y02A50/471Y02A50/473Y02A50/475Y02A50/478Y02A50/481Y02A50/483
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Quick Facts
Patent No.
US 10,792,289
App. No.
16/263,886
Granted
Oct 6, 2020
Kind
B2
Abstract

Methods for treating cystic fibrosis. The method includes administering to a human in need thereof an aerosol solution comprising levofloxacin or ofloxacin and a divalent or trivalent cation. More particularly, the method includes administering the aerosol solution to a human having a pulmonary infection comprising P. aeruginosa.

Claims (10)

1. A method for treating a pulmonary infection, wherein the pulmonary infection comprises one or more Mycobacterium , the method comprising:

administering via inhalation 240 mg of levofloxacin twice daily for 28 days to the human having cystic fibrosis to treat the Mycobacterium pulmonary infection;

wherein the levofloxacin is in an aerosol of a solution comprising levofloxacin at a concentration from about 90 mg/ml to about 110 mg/ml, a magnesium cation at a concentration from about 175 mM to about 225 mM, wherein the solution has a pH from about 5 to about 7, and an osmolality from about 300 mOsmol/kg to about 500 mOsmol/kg.

2. The method of claim 1 , wherein the Mycobacterium is Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium intracellulare , or Mycobacterium leprae.

3. The method of claim 2 , wherein the Mycobacterium is Mycobacterium avium or Mycobacterium intracellulare.

4. The method of claim 1 , wherein the magnesium cation is in the form of magnesium chloride.

5. The method of claim 1 , wherein the solution comprises a levofloxacin concentration of about 100 mg/ml, a magnesium chloride concentration of about 200 mM, a pH between about 6.0 to about 6.5, and an osmolality of between about 300 mOsmol/kg to about 500 mOsmol/kg, and lacks lactose.

6. The method of claim 1 , wherein the aerosol of the solution comprises a mass median aerodynamic diameter from about 2 microns to about 5 microns with a geometric standard deviation less than or equal to 2.5 microns.

7. The method of claim 1 , wherein the aerosol is produced by a vibrating mesh nebulizer.

8. The method of claim 1 , further comprising administering an antibiotic, a bronchodilator, an anticholinergic agent, a glucocorticoid, an eicosanoid inhibitor, or a combination of two or more thereof.

Assignments (7)
MERGER AND CHANGE OF NAME Recorded Dec 21, 2023
From: HORIZON THERAPEUTICS, LLC; HORIZON ORPHAN LLC
To: HORIZON THERAPEUTICS U.S. HOLDING LLC
Reel/Frame 065928/0608 →
RELEASE OF SECURITY INTEREST Recorded Oct 6, 2023
From: CITIBANK, N.A.
To: HORIZON THERAPEUTICS U.S. HOLDING LLC (FKA HORIZON ORPHAN LLC); HZNP LIMITED; HORIZON THERAPEUTICS U.S. HOLDING LLC (SUCCESSOR IN INTEREST TO HORIZON THERAPEUTICS, LLC)
Reel/Frame 065154/0041 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2021
From: MPEX PHARMACEUTICALS, INC.
To: TRIPEX PHARMACEUTICALS, LLC
Reel/Frame 056383/0920 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2021
From: TRIPEX PHARMACEUTICALS, LLC
To: RAPTOR PHARMACEUTICALS INC.
Reel/Frame 056422/0235 →
CHANGE OF NAME Recorded May 28, 2021
From: RAPTOR PHARMACEUTICALS INC.
To: HORIZON ORPHAN LLC
Reel/Frame 056424/0102 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 27, 2021
From: LOUTIT, JEFFREY S; MORGAN, ELIZABETH E; DUDLEY, MICHAEL N; GRIFFITH, DAVID C; LOMOVSKAYA, OLGA
To: MPEX PHARMACEUTICALS, INC.
Reel/Frame 056377/0066 →
SECURITY AGREEMENT Recorded Aug 17, 2020
From: HORIZON ORPHAN LLC; HORIZON THERAPEUTICS, LLC; HZNP LIMITED
To: CITIBANK, N.A.
Reel/Frame 053515/0273 →