Compositions and methods for treatment of chronic fatigue

• US 9,040,082 B2
• Filed: 06/22/2012
• Issued: 05/26/2015
• Est. Priority Date: 06/24/2011
• Status: Active Grant

• Current Assignee: K-PAX Pharmaceuticals, Inc.
• Original Assignee: K-PAX Pharmaceuticals, Inc.
• Inventors: Kaiser, Jon D.
• Primary Examiner(s): Singh, Anoop
• Assistant Examiner(s): PHAN, DOAN THI-THUC
• Application Number:
  US13/530,673
• Publication Number:
  US 20120328695A1
• Time in Patent Office: 1,068 Days
• Field of Search: 424/451, 514/263.31, 514/317
• US Class Current: 424/451
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: 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
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/385 having two or more sulfur atoms in the same ring
• CPC Class Codes: A61K 31/4415 Pyridoxine, i.e. Vitamin B6 pyridoxal phosphate A61K31/675
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: 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
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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

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.

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

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

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

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

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

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

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

9. 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.

10. 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.

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

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

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