IP Library Granted Patent US 9,763,903
Granted Patent B2
US 9,763,903 · App. 15/059,602 · Granted Sep 19, 2017

Compositions and methods for treating intestinal hyperpermeability

Inventor: Steven Hoffman (Mahwah, NJ)
Assignee: Steven Hoffman
A61K31/198A61K9/0053A61K31/137A61K31/197A61K31/4166A61K45/06
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Quick Facts
Patent No.
US 9,763,903
App. No.
15/059,602
Granted
Sep 19, 2017
Kind
B2
Abstract

The present invention provides methods, compositions, and kits for treating intestinal hyperpermeability in a subject in need thereof, including conditions such as hyperglycemia and underlying diseases such as diabetes, autism, fibromyalgia, inflammatory bowel disease (IBD), graft versus host disease (GVHD), HIV/AIDS, multiple organ dysfunction syndrome, irritable bowel syndrome (IBS), celiac disease, eczema, psoriasis, acute pancreatitis, Parkinson's disease, depression, chronic fatigue syndrome, asthma, multiple sclerosis, arthritis, ankylosing spondylitis, nonalcoholic fatty liver disease, alcoholic cirrhosis, environmental enteropathy, or kwashiorkor.

Claims (34)

1. A method of treating autism comprising administering to a subject in need thereof an effective amount of α-methyl-DL-tyrosine and an effective amount of γ-aminobutyric acid (GABA).

2. The method of claim 1 wherein the α-methyl-DL-tyrosine and GABA are administered simultaneously.

3. The method of claim 1 , wherein the α-methyl-DL-tyrosine and GABA are administered separately.

4. The method of claim 1 wherein the α-methyl-DL-tyrosine is administered orally.

5. The method of claim 1 wherein 150-300 mg of the α-methyl-DL-tyrosine is administered daily.

6. The method of claim 5 wherein the α-methyl-DL-tyrosine is administered in three substantially equal doses.

7. The method of claim 1 , wherein about 5 to about 30 mg of the GABA is administered daily.

8. The method of claim 1 , wherein about 15 mg of the GABA is administered daily.

9. The method of claim 1 , further comprising administering an effective amount of a p450 3A4 promoter.

10. The method of claim 9 , wherein the p450 3A4 promoter is 5,5-diphenylhydantoin, valproic acid, or carbamazepine.

11. The method of claim 1 that reduces at least one of the following autism symptoms:

deficits in social-emotional reciprocity;

deficits in nonverbal communicative behaviors used for social interaction;

deficits in developing, maintaining, and understanding relationships stereotyped or repetitive motor movements, use of objects, or speech;

insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior;

highly restricted, fixated interests that are abnormal in intensity or focus; and

hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment.

12. The method of claim 1 , wherein the method results in a reduction in at least one dimension of the Conners Parent Rating Scale assessment score.

13. The method of claim 12 , wherein the method results in a reduction of at least 1 point in at least one dimension of the Conners Parent Rating Scale assessment score.

14. The method of claim 1 , wherein the method results in a reduction in an irritability, lethargy, stereotypy, hyperactivity, and/or speech Aberrant Behavior Checklist-Community (ABC-C) assessment score.

15. The method of claim 14 , wherein the method results in a reduction of at least 1 point in the irritability, lethargy, stereotypy, hyperactivity, and/or speech ABC-C score.

16. A method of treating tics or a symptom of Attention Deficit Disorder in a subject who has been diagnosed with autism, autism spectrum disorder, Asperger Syndrome, or Social Communication Disorder, comprising administering to the subject an effective amount of α-methyl-DL-tyrosine and an effective amount of a beta adrenergic agonist that is albuterol, levalbuterol, fenoterol, formoterol, isoproterenol, metaproterenol, salmeterol, terbutaline, clenbuterol, isoetarine, pirbuterol, procaterol, ritodrine, epinephrine, or a combination thereof.

17. The method of claim 16 , wherein the beta adrenergic agonist is albuterol, levalbuterol, or a combination thereof.

18. The method of claim 16 , wherein the beta adrenergic agonist is albuterol.

19. The method of claim 16 wherein the α-methyl-DL-tyrosine and the beta adrenergic agonist are administered simultaneously.

20. The method of claim 16 , wherein the α-methyl-DL-tyrosine and the beta adrenergic agonist are administered separately.

21. The method of claim 16 , wherein the α-methyl-DL-tyrosine is administered orally.

22. The method of claim 16 , wherein 150-300 mg of the α-methyl-DL-tyrosine is administered daily.

23. The method of claim 22 , wherein the α-methyl-DL-tyrosine is administered in three substantially equal doses.

24. The method of claim 16 , wherein the tics are motor tics.

25. The method of claim 16 , for the treatment of a symptom of Attention Deficit Disorder.

26. The method of claim 16 , wherein the subject has been diagnosed with autism spectrum disorder.

27. The method of claim 16 , wherein the subject has been diagnosed with Asperger Syndrome.

28. The method of claim 16 , wherein the subject has been diagnosed with Social Communication Disorder.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 1, 2018
From: HOFFMAN, STEVEN
To: HOFFMAN TECHNOLOGIES LLC
Reel/Frame 044803/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 1, 2018
From: HOFFMAN TECHNOLOGIES LLC
To: YAMO PHARMACEUTICALS LLC
Reel/Frame 045230/0726 →
Continuity (5)
Continuation In Part 14686545 · Apr 14, 2015
Continuation 14520116 · Oct 21, 2014
Continuation In Part 14062165 · Oct 24, 2013
Provisional Application 61894261 · Oct 22, 2013
Related Publication 20160193169A1 · Jul 7, 2016