US2015250761A1PendingUtilityA1

Compositions and methods for treatment of chronic fatigue

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Assignee: K PAX PHARMACEUTICALS INCPriority: Jun 24, 2011Filed: May 6, 2015Published: Sep 10, 2015
Est. expiryJun 24, 2031(~4.9 yrs left)· nominal 20-yr term from priority
Inventors:Jon D. Kaiser
A61P 43/00A61P 25/28A61K 31/522A61K 31/137A61K 31/4415A61K 31/145A61K 31/205A61P 25/00A61K 45/06A61K 31/185A61K 31/385A61K 31/714A61K 31/165A61K 31/4458A61K 31/198A61K 31/138A61P 21/00
33
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Claims

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

exact text as granted — not AI-modified
1 . An oral dosage composition for the treatment of chronic fatigue, comprising:
 a central nervous system stimulant in a therapeutically effective low-dosage amount;   a therapeutically effective amount of a micronutrient stimulant component comprising L-carnitine and L-tyrosine; and   a therapeutically effective amount of a micronutrient antioxidant component comprising N-acetyl cysteine and alpha-lipoic acid.   
     
     
         2 . The composition of  claim 1 , wherein acetyl L-carnitine is present in a range of 60 to 250 mg. 
     
     
         3 . The composition of  claim 1 , wherein acetyl L-carnitine is present in a range of 100 to 150 mg. 
     
     
         4 . The composition of  claim 1 , wherein L-tyrosine is present in a range of 50 to 200 mg. 
     
     
         5 . The composition of  claim 1 , wherein L-tyrosine is present in a range of 80 to 100 mg. 
     
     
         6 . The composition of  claim 1 , wherein N-acetyl cysteine is present in a range of 60 to 250 mg. 
     
     
         7 . The composition of  claim 1 , wherein N-acetyl cysteine is present in a range of 100 to 150 mg. 
     
     
         8 . The composition of  claim 1 , wherein alpha-lipoic acid is present in a range of 25 to 100 mg. 
     
     
         9 . The composition of  claim 1 , wherein alpha-lipoic acid is present in a range of 40 to 60 mg. 
     
     
         10 . The composition of  claim 1 , further comprising about 25 to 100 mg L-taurine. 
     
     
         11 . The composition of  claim 10 , wherein L-taurine is present in a range of 35 to 75 mg. 
     
     
         12 . The composition of  claim 1 , wherein the central nervous system stimulant is atomoxetine HCl in an amount of about 2 mg to 20 mg. 
     
     
         13 . The composition of  claim 1 , wherein the central nervous system stimulant is methylphenidate HCl in the amount of about 0.75 mg to 7.5 mg. 
     
     
         14 . The composition of  claim 1 , wherein the central nervous system stimulant is dexmethylphenidate HCl in the amount of about 0.5 mg to 5 mg. 
     
     
         15 . The composition of  claim 1 , wherein the central nervous system stimulant is modafinil in the amount of about 4 mg to 40 mg. 
     
     
         16 . The composition of  claim 1 , wherein the central nervous system stimulant is armodafinil in the amount of 4 mg to 40 mg. 
     
     
         17 . The composition of  claim 1 , wherein the central nervous system stimulant is an amphetamine in the amount of about 1 mg to 10 mg. 
     
     
         18 . The composition of  claim 1 , further comprising one or more of vitamin B6 (pyridoxine) and vitamin B12. 
     
     
         19 . The composition of  claim 1 , further comprising one or more of vitamin C, vitamin E, beta carotene, zinc and selenium. 
     
     
         20 . The composition of  claim 1 , wherein the composition comprises acetyl L-carnitine, L-tyrosine, vitamin B6 (pyridoxine), vitamin B12, N-acetyl cysteine, alpha-lipoic acid, L-taurine, vitamin C, vitamin E and beta carotene. 
     
     
         21 . The composition of  claim 20 , further comprising of one or more additional vitamins or minerals selected from the group consisting of zinc, selenium, mixed tocopherols, vitamin B1 (thiamine), vitamin B2 (riboflavin), niacinamide, calcium pantothenate, choline (bitartrate), inositol, folic acid (folacin), biotin, vitamin D3 (cholicalciferol), calcium, magnesium, iron, iodine, copper, manganese, potassium, chromium, molybdenum and boron. 
     
     
         22 . The composition of  claim 1 , wherein the stimulant and micronutrient components are combined together in a pill, tablet, capsule or liquid dosage form. 
     
     
         23 . A method for treating chronic fatigue in a human patient comprising:
 administering a daily low-dosage amount of a central nervous system stimulant; and   administering daily therapeutically effective dosages of acetyl L-carnitine,   L-tyrosine,   N-acetyl cysteine, and   alpha lipoic acid.   
     
     
         24 . The method of  claim 23 , wherein acetyl L-carnitine is administered in a range of about 100 to 2000 mg/d. 
     
     
         25 . The method of  claim 23 , wherein acetyl L-carnitine is administered in a range of about 400 to 1600 mg/d. 
     
     
         26 . The method of  claim 23 , wherein L-tyrosine is administered in a range of about 100 to 2000 mg/d. 
     
     
         27 . The method of  claim 23 , wherein L-tyrosine is administered in a range of 350 to 1400 mg/d. 
     
     
         28 . The method of  claim 23 , wherein N-acetyl cysteine is administered in a range of 100 to 2000 mg/d. 
     
     
         29 . The method of  claim 23 , wherein N-acetyl cysteine is administered in a range of 250 to 1250 mg/d. 
     
     
         30 . The method of  claim 23 , wherein alpha-lipoic acid is administered in a range of 50 to 1000 mg/d. 
     
     
         31 . The method of  claim 23 , wherein alpha-lipoic acid is administered in a range of 150 to 600 mg/d. 
     
     
         32 . The method of  claim 23 , wherein said administering is conducted on a continuous basis for at least 12 weeks. 
     
     
         33 . The method of  claim 23 , wherein the chronic fatigue is associated with Chronic Fatigue Syndrome. 
     
     
         34 . The method of  claim 23 , wherein the chronic fatigue is associated with fibromyalgia. 
     
     
         35 . The method of  claim 23 , 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, psychological disorders including depression, ADD and ADHD, multiple sclerosis, sickle cell anemia, and congestive heart failure. 
     
     
         36 . The method of  claim 23 , wherein the CNS stimulant, acetyl L-carnitine, L-tyrosine, N-acetyl cysteine, and alpha lipoic acid are orally administered together in a combined dosage form. 
     
     
         37 . The method of  claim 23 , wherein the CNS stimulant comprises methylphenidate. 
     
     
         38 . The method of  claim 37 , wherein the methylphenidate is administered in an amount of 2.5 to 40 mg/day. 
     
     
         39 . The method of  claim 38 , wherein the methylphenidate is administered in an amount less than 20 mg/day. 
     
     
         40 . The method of  claim 23 , wherein the CNS stimulant comprises modafinil. 
     
     
         41 . The method of  claim 37 , wherein the modafinil is administered in an amount of 30 to 100 mg/day. 
     
     
         42 . The method of  claim 38 , wherein the modafinil is administered in an amount of 30 to 50 mg/day. 
     
     
         43 . The method of  claim 23 , wherein the CNS stimulant comprises armodafinil. 
     
     
         44 . The method of  claim 37 , wherein the armodafinil is administered in an amount of 20 to 80 mg/day. 
     
     
         45 . The method of  claim 38 , wherein the armodafinil is administered in an amount of 20 to 40 mg/day. 
     
     
         46 . The method of  claim 23 , wherein the CNS stimulant comprises dexmethylphenidate. 
     
     
         47 . The method of  claim 37 , wherein the dexmethylphenidate is administered in an amount of 2.5 to 10 mg/day. 
     
     
         48 . The method of  claim 38 , wherein the dexemthylphenidate is administered in an amount of 2.5 to 5 mg/day. 
     
     
         49 . The method of  claim 23 , wherein the CNS stimulant comprises an amphetamine. 
     
     
         50 . The method of  claim 37 , wherein the amphetamine is administered in an amount of 2.5 to 20 mg/day. 
     
     
         51 . The method of  claim 38 , wherein the amphetamine is administered in an amount of 2.5 to 10 mg/day. 
     
     
         52 . The method of  claim 23 , wherein the CNS stimulant comprises atomoxetine. 
     
     
         53 . The method of  claim 37 , wherein the atomoxetine is administered in an amount of 20 to 50 mg/day. 
     
     
         54 . The method of  claim 38 , wherein the atomoxetine is administered in an amount of 20 to 25 mg/day. 
     
     
         55 . The method of  claim 23 , wherein the CNS stimulant comprises caffeine. 
     
     
         56 . The method of  claim 55 , wherein the caffeine is administered in an amount of 15 to 200 mg/day. 
     
     
         57 . The method of  claim 55 , wherein the caffeine is administered in an amount of 30 to 125 mg/day.

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