IP Library Granted Patent US 10,813,901
Granted Patent B2
US 10,813,901 · App. 16/040,405 · Granted Oct 27, 2020

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
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,813,901
App. No.
16/040,405
Granted
Oct 27, 2020
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 (28)

1. A method for providing a plasma concentration of a therapeutic drug for a long term for treating an autism in a subject in need thereof, the method comprising administering to said subject said therapeutic drug at a concentration ranging from about 50 mg (w/w) to about 1500 mg (w/w) daily, wherein said therapeutic drug is α-methyl-DL-tyrosine, wherein said plasma concentration ranges from about 500 ng/ml to 5000 ng/ml, and wherein said term is at least 1 week.

2. The method of claim 1 , wherein the concentration of said therapeutic drug is about 90 mg (w/w/).

3. The method of claim 1 , wherein the concentration of said therapeutic drug is about 100 mg (w/w/).

4. The method of claim 1 , wherein the concentration of said therapeutic drug is about 200 mg (w/w/).

5. The method of claim 1 , wherein the concentration of said therapeutic drug is about 250 mg (w/w/).

6. The method of claim 1 , wherein the concentration of said therapeutic drug is about 300 mg (w/w/).

7. The method of claim 1 , wherein the concentration of said therapeutic drug is about 350 mg (w/w/).

8. The method of claim 1 , wherein said therapeutic drug is administered in a plurality of divided doses.

9. The method of claim 1 , wherein said therapeutic drug is administered for a duration ranging from about 1 week to about 4 weeks or more.

10. The method of claim 1 , wherein said plasma concentration ranges from about 800 ng/ml to 2500 ng/ml.

11. The method of claim 1 , wherein said plasma concentration ranges from about 1400 ng/ml to 1800 ng/ml.

12. A method for treating an autism associated clinical trait in a subject in need thereof, the method comprising administering to said subject a composition comprising a therapeutically effective amount of α-methyl-DL-tyrosine, thereby treating said autism associated clinical trait in said subject.

13. The method of claim 12 , wherein said clinical trait is a deficit in social communication, a deficit in social interaction, a deficit in social motivation, lethargy and social withdrawal, inappropriate speech, hyperactivity, stereotypic behavior, irritability and agitation, restrictive behavior, repetitive behavior, ritualistic behavior, sameness behavior, compulsive behavior, self-injurious behavior or a combination thereof.

14. The method of claim 12 , wherein said clinical trait meets the requirements of Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.

15. The method of claim 12 , wherein said clinical trait is assessed based upon a change from a baseline in one or more psychometric tests.

16. The method of claim 15 , wherein said psychometric test is based on clinical global impression (CGI) rating scale, Vineland adoptive behavior scale (VABS), autism diagnostic observation schedule (ADOS), social responsiveness scale (SRS), aberrant behavior checklist-community (ABC-C), repetitive behavior scale (RBS), Conners parent rating scale (CPRS), or a combination thereof.

17. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount ranging from about 50 mg (w/w) to about 1000 mg (w/w).

18. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount of about 90 mg (w/w/).

19. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount of about 100 mg (w/w/).

20. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount of about 200 mg (w/w/).

21. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount of about 250 mg (w/w/).

22. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount of about 300 mg (w/w/).

23. The method of claim 12 , wherein the composition comprises α-methyl-DL-tyrosine in an amount of about 350 mg (w/w/).

24. The method of claim 12 , wherein the composition is administered in a plurality of divided doses.

25. The method of claim 12 , wherein the composition is administered three times per day.

26. The method of claim 12 , wherein the composition is administered for at least 1 week.

27. The method of claim 12 , wherein the composition is administered for a duration ranging from about 1 week to about 4 weeks.

28. A method for providing a plasma concentration of a therapeutic drug for a long term for treating an autism in a subject in need thereof, the method comprising administering to said subject said therapeutic drug at a concentration ranging from about 50 mg (w/w) to about 500 mg (w/w) daily, wherein said therapeutic drug is α-methyl-DL-tyrosine, wherein said plasma concentration ranges from about 500 ng/ml to 5000 ng/ml, and wherein said term is at least 1 week.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 6, 2020
From: HOFFMAN TECHNOLOGIES LLC
To: YAMO PHARMACEUTICALS LLC
Reel/Frame 053121/0727 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2019
From: HOFFMAN, STEVEN; ROTHMAN, JOHN
To: HOFFMAN TECHNOLOGIES LLC
Reel/Frame 051341/0990 →
Continuity (6)
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 20190015365A1 · Jan 17, 2019
Cited By (1)
US 12,453,709