IP Library Granted Patent US 12,453,709
Granted Patent B2
US 12,453,709 · App. 18/305,826 · Granted Oct 28, 2025

Compositions and methods for treating autism

Inventors: Steven Hoffman (Mahwah, NJ); John Rothman (Lebanon, NJ)
Assignee: YAMO PHARMACEUTICALS LLC
A61K31/198A61K9/0019A61K9/0053A61K9/48A61K31/19A61K31/4166A61K31/55A61K45/06A61K2300/00
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Quick Facts
Patent No.
US 12,453,709
App. No.
18/305,826
Granted
Oct 28, 2025
Kind
B2
Abstract

The invention provides compositions and methods of treating autism. Specifically, the invention relates to treating the core symptoms of autism by administering α-methyl-DL-tyrosine.

Claims (22)

1. A method for treating a disorder that is Asperger's Disorder (Asperger Syndrome) or Social Communication Disorder in a human in need thereof, comprising:

administering a daily amount of about 50 mg (w/w) to about 1500 mg (w/w) of α-methyl-DL-tyrosine for a term of at least one week.

2. The method of claim 1 , further comprising administering to the human an effective amount of a beta adrenergic agonist for a term of at least one week.

3. The method of claim 2 , wherein beta adrenergic agonist is albuterol, levalbuterol, fenoterol, formoterol, isoproterenol, metaproterenol, salmeterol, terbutaline, clenbuterol, isoetarine, pirbuterol, procaterol, ritodrine, epinephrine, or combinations thereof.

4. The method of claim 1 , wherein the disorder is Asperger's Disorder.

5. The method of claim 1 , wherein the disorder is Social Communication Disorder.

6. The method of claim 1 , wherein the daily amount of α-methyl-DL-tyrosine administered to the human is about 100 mg.

7. The method of claim 1 , wherein the daily amount of α-methyl-DL-tyrosine administered to the human is about 200 mg.

8. The method of claim 1 , wherein the daily amount of α-methyl-DL-tyrosine administered to the human is about 250 mg.

9. The method of claim 1 , wherein the daily amount of α-methyl-DL-tyrosine administered to the human is about 300 mg.

10. The method of claim 1 , wherein the daily amount of α-methyl-DL-tyrosine administered to the human is about 350 mg.

11. The method of claim 1 , wherein the daily amount of α-methyl-DL-tyrosine is administered in divided doses.

12. The method of claim 11 , wherein the daily amount of α-methyl-DL-tyrosine is administered in two doses.

13. The method of claim 11 , wherein the daily amount of α-methyl-DL-tyrosine is administered in three doses.

14. The method of claim 1 , wherein the term is from about 1 week to about 4 weeks.

15. The method of claim 1 , wherein the term is more than 4 weeks.

16. The method of claim 1 , wherein the term is at least 12 weeks.

17. The method of claim 1 , wherein the administration results in a change from baseline on the Vineland Adaptive Behavior Scales-3rd Edition (VABS-3).

18. The method of claim 1 , wherein the α-methyl-DL-tyrosine and beta adrenergic agonist are administered simultaneously.

19. A method for treating a disorder that is Asperger's Disorder in a human in need thereof, comprising administering to the human 200 mg to 300 mg of α-methyl-DL-tyrosine twice daily for a term of 12 weeks.

20. The method of claim 19 , further comprising administering an effective amount of a beta adrenergic agonist to the human for a term of 12 weeks.

21. The method of claim 19 , wherein the administration results in a change from baseline on the Vineland Adaptive Behavior Scales-3rd Edition (VABS-3).

Continuity (8)
Continuation 17067949 · Oct 12, 2020
Continuation 16040405 · Jul 19, 2018
Continuation In Part 15695327 · Sep 5, 2017
Continuation 15138733 · Apr 26, 2016
Continuation 14520116 · Oct 21, 2014
Continuation In Part 14062165 · Oct 24, 2013
Provisional Application 61894261 · Oct 22, 2013
Related Publication 20230310358A1 · Oct 5, 2023
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