# US 9,040,082 B2 · Compositions and methods for treatment of chronic fatigue

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- Number: US 9,040,082 B2
- Document ID: US9040082B2
- Status: Granted
- Kind: B2
- Application number: 13/530,673
- Filed: 2012-06-22
- Published: 2012-12-27
- Granted: 2015-05-26
- Earliest claimed: 2011-06-24
- Assignees: K-PAX Pharmaceuticals, Inc.
- Applicants: Jon D. Kaiser
- Inventors: Jon D. Kaiser
- Web page: https://patentgrep.com/patent/US9040082B2

## CPC

- A61K 31/385: having two or more sulfur atoms in the same ring
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/145: having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2) (isothiourea A61K31/155)
- A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K 31/185: Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids (hydroxamic acids A61K31/16; peroxy acids A61K31/327)
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/4458: only substituted in position 2, e.g. methylphenidate
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

Pharmaceutical compositions and methods for the treatment of chronic fatigue in human patients comprising a central nervous system (CNS) stimulant in a daily low-dosage amount in combination with therapeutically effective daily amounts of micronutrients, comprising acetyl L-carnitine, L-tyrosine, N-acetyl cysteine, and alpha-lipoic acid. The CNS and micronutrient components may be in an oral dosage composition containing a low dosage amount of CNS stimulant such as about 2.5 mg methylphenidate HCl together with about 60-250 mg acetyl L-carnitine, 50-200 mg L-tyrosine, 60-250 mg N-acetyl cysteine, and 25-100 mg alpha-lipoic acid.

## Claims

### Claim 1

A method for treating chronic fatigue in a human patient comprising:
administering a daily dosage of about 2.5 to 40 mg methylphenidate; and
administering daily about 100 to 2000 mg acetyl L-carnitine,
about 100 to 2000 mg L-tyrosine,
about 100 to 2000 mg N-acetyl cysteine, and
about 50 to 1000 mg alpha lipoic acid.

### Claim 2 (depends on 1)

The method of claim 1, wherein acetyl L-carnitine is administered in a Range of about 400 to 1600 mg/d.

### Claim 3 (depends on 1)

The method of claim 1, wherein L-tyrosine is administered In a range of about 350 to 1400 mg/d.

### Claim 4 (depends on 1)

The method of claim 1, wherein N-acetyl cysteine is administered in a range of about 250 to 1250 mg/d.

### Claim 5 (depends on 1)

The method of claim 1, wherein alpha-lipoic acid is administered in a range of about 150 to 600 mg/d.

### Claim 6 (depends on 1)

The method of claim 1, wherein said administering is conducted on a continuous basis for at least 12 weeks.

### Claim 7 (depends on 1)

The method of claim 1, wherein the chronic fatigue is associated with Chronic Fatigue Syndrome.

### Claim 8 (depends on 1)

The method of claim 1, wherein the chronic fatigue is associated with fibromyalgia.

### Claim 9 (depends on 1)

The method of claim 1, wherein the chronic fatigue is associated with a condition selected from the group of cancer, HIV/AIDS, chronic hepatitis B & C, autoimmune disorders, Lyme's disease, Parkinson's disease, Alzheimer's disease, depression, ADD, ADHD, multiple sclerosis, sickle cell anemia, and congestive heart failure.

### Claim 10 (depends on 1)

The method of claim 1, wherein the methylphenidate, acetyl L-carnitine, L-tyrosine, N-acetyl cysteine, and alpha lipoic acid are orally administered together in a combined dosage form.

### Claim 11 (depends on 1)

The method of claim 1, wherein the methylphenidate comprises methylphenidate HCl.

### Claim 12 (depends on 1)

The method of claim 1, wherein the methylphenidate is administered in an amount of about 5 to 40 mg/day.

### Claim 13 (depends on 1)

The method of claim 1, wherein the methylphenidate is administered in an amount less than 20 mg/day.