# US 10,864,229 B2 · Use of nitrite salts in chronic ischemia

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- Number: US 10,864,229 B2
- Document ID: US10864229B2
- Status: Granted
- Kind: B2
- Application number: 15/483,187
- Filed: 2017-04-10
- Published: 2017-11-02
- Granted: 2020-12-15
- Earliest claimed: 2007-11-15
- Assignees: Board of Supervisors of Louisiana State University
- Applicants: The UAB Research Foundation; The Board of Supervisors of Louisiana State University and Agricultural and Mechanical College
- Inventors: Christopher Kevil; David Lefer; Rakesh Patel
- Web page: https://patentgrep.com/patent/US10864229B2

## CPC

- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 25/02: for peripheral neuropathies
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Methods of treating a subject who has chronic tissue ischemia are disclosed. The methods can include administering to the subject a pharmaceutical composition comprising inorganic nitrite or a pharmaceutically acceptable salt thereof, for a time and in an amount sufficient to result in blood vessel growth in the ischemic tissue. The subject can be diagnosed as having a medical condition that results in persistent or recurring restriction of blood supply to a tissue, for example, peripheral artery disease, diabetes, atherosclerotic cardiovascular disease or defective wound healing. The methods can include the step of identifying a suitable subject.

## Claims

### Claim 1

A method of treating peripheral neuropathy in a human subject, the method comprising: orally administering to the subject a pharmaceutical composition comprising about 5 mg to about 50 mg of sodium nitrite one to six times per day for at least ten days, thereby treating the peripheral neuropathy.

### Claim 2 (depends on 1)

The method of claim 1, further comprising a step of ceasing the administration of the pharmaceutical composition when a symptom of peripheral neuropathy in the subject improves.

### Claim 3 (depends on 2)

The method of claim 2, wherein the sodium nitrite is administered to a circulating nitrite concentration in the subject of about 0.01 M to about 0.6 M.

### Claim 4 (depends on 2)

The method of claim 2, wherein the method stimulates blood vessel growth in ischemic tissue but not in non-ischemic tissue.

### Claim 5 (depends on 4)

The method of claim 4, wherein the ischemic tissue comprises skeletal muscle, smooth muscle, cardiac muscle, neuronal tissue, skin, mesenchymal tissue, connective tissue, gastrointestinal tissue or bone.

### Claim 6 (depends on 5)

The method of claim 5, wherein administration of said sodium nitrite alters nitrite levels in the blood.

### Claim 7 (depends on 5)

The method of claim 5, wherein administration of said sodium nitrite raises nitrite levels in the ischemic tissue.

### Claim 8 (depends on 1)

The method of claim 1, wherein the sodium nitrite is administered two times per day.